MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

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Model Number M0068505001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Erosion (1750); Diarrhea (1811); Fatigue (1849); Fever (1858); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Nerve Damage (1979); Pain (1994); Perforation (2001); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Hot Flashes/Flushes (2153); Chills (2191); Stenosis (2263); Urinary Frequency (2275); Prolapse (2475); Hematuria (2558); Weight Changes (2607); Dysuria (2684); Fibrosis (3167); Constipation (3274); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Unspecified Tissue Injury (4559); Fecal Incontinence (4571); Insufficient Information (4580)

Event Date 08/13/2010

Event Type Injury

Manufacturer Narrative

Date of event was approximated to (b)(6) 2010, implant date, as no event date was reported.This event was reported by the patient's legal representation.The device was implanted at: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Manufacturer Narrative

Additional information: blocks a2, a3, b2, b3, b5, b7, e1 (below), h6: patient codes and h6: impact codes.Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2018 was chosen as a best estimate based on the date of the first mesh removal surgery in (b)(6) 2018.Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6) hospital.(b)(6) 2020 mesh removal performed by: dr.(b)(6).Block h6: patient codes e1405, e2015, e1906, e2330, e2006 and e1310 capture the reportable events of dyspareunia, atrophy, purulent drainage, pain, mesh erosion and urinary tract infection.Impact codes f1901 and f1903 capture the reportable events of surgical intervention and mesh removal.Block h10 the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Manufacturer Narrative

Block b3: the exact event onset date is unknown; however, it was reported that the patient had a first office visit on (b)(6) 2010 due to symptoms.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Explant surgeon is: dr.(b)(6).Block h6: patient codes e2006, e1309, e2114, e1405, e232401, e2330, e1906, e1310, e2015, e0123, and e2101 capture the reportable events of erosion, urinary retention, perforation, dyspareunia, fecal incontinence, pain, unspecified infection, urinary tract injury, unspecified tissue injury, nerve damage and adhesion.Impact codes f1901 and f1903 capture the reportable events of surgical intervention and mesh removal.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10 the removed mesh is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2010, a hysterectomy was performed prior to the sling placement.The operative report for the obtryx implant notes that on the patient left side, there was some perforation of the skin lateral to the vaginal incision on the left which was recognized and the needle was placed beneath this.Cystoscopy was performed and the operative report states the patient had some methylene blue which made visualization a bit difficult.There was some redundant vaginal mucosa along the left trigone.The remainder of the bladder was free of any lesions, stones, or foreign bodies.On (b)(6) 2010, the patient presented with recurrent urinary tract infections utis that seemed worse since the obtryx surgery.One uti had been associated with fever and low blood pressure and had developed while she was on macrobid.The patient also had hesitancy and incomplete emptying.She denied any leakage.Urinalysis was performed and culture was submitted.Post void residual pvr via bladder scan was 147 ml.The assessment included chronic cystitis and incomplete bladder emptying.The plan was for the patient to continue macrobid, and undergo uroflow, cystourethroscopy, and cystogram.It was noted that the sling may need to be incised if the recurrent utis could not be controlled.On (b)(6) 2015, the patient presented for evaluation of urinary retention.She reported no pain and no leakage.She denied constipation, dysuria, fever, urinary frequency, hematuria, and history of diabetes.She had been self-catheterizing 6 times per day for 2 years with minimal voiding in between.The visit notes indicate the patient had undergone cystogram in (b)(6) 2010 which showed incomplete emptying but she never did any follow up.In 2012, cystometrogram showed the patient was without desire and 600 cc was drained.The patient had undergone an unspecified number of cystoscopies.The patient had intermittent utis.Genitourinary exam revealed no abnormalities.The medical record notes that possibly sling was obstructive and has slowly damaged bladder over the years and now does clean intermittent catheterization cic.The patient declined further evaluation at this time and noted she would call the physician if needed.On (b)(6) 2020, the patient presented for second opinion regarding vaginal mesh erosion and recurrent utis.She has a longstanding history of a neurogenic bladder and interstitial cystitis.She underwent an ileal conduit and simple versus radical cystectomy and urethral sling removal in (b)(6) 2018.However, the patient reported remnant of the mesh in her vagina.Furthermore, the patient reported the following during the visit: dyspareunia; vaginal bleeding postcoital; symptomatic with the recurrent utis including flank pain, chills, nausea, and purulent drainage from her urostomy.She had been on multiple rounds of antibiotics; improvement on her cystitis post cystectomy and conduit.Physical exam noted the ileal conduit with a healthy-appearing stoma, clear urine in the urostomy bag, and a small fragment of eroded vaginal mesh at the left apex of the vagina.The assessments were as follows: neurogenic bladder status post heal conduit (b)(6) 2018, recurrent utis postoperatively, dyspareunia secondary to eroded vaginal mesh, history of interstitial cystitis, neurogenic bowel.The patient was advised regarding her dyspareunia and eroded vaginal mesh that options included doing nothing versus removal if she is symptomatic.The patient wanted to have her eroded vaginal mesh removed as intercourse was painful.The patient was advised that with her history of interstitial cystitis and multiple pelvic surgeries that she may continue to have dyspareunia and or pain post mesh removal.We also discussed that repeat surgeries can lead to recurrent scar tissue and increased pain.On (b)(6) 2020, the patient presented due to erosion of implanted vaginal mesh to surrounding organ or tissue and underwent an excision of eroded vaginal mesh; transvaginal enterocele repair; looposcopy and sling removal.Her postoperative diagnoses included erosion of implanted vaginal mesh to surrounding organ or tissue and enterocele.Additionally, findings during the procedure included: eroded mesh seen along the left suburethral region extending toward the left endopelvic fascia.Atrophic.Peritoneum was seen extruding through the vagina and the suburethral mesh was adherent to the peritoneum and vagina.The peritoneum was separated off the vaginal wall.However, the mesh was adherent to the peritoneum and both the mesh and peritoneum were excised in their entirety in the suburethral region extending to the left endopelvic fascia.The enterocele was reduced and the peritoneum closed using 3-0 vicryl.The remnants of mesh at the left endopelvic fascia were placed on traction and excised in entirety.There is no visible mesh seen at this time.Her ileal conduit had a healthy stoma and there were no foreign bodies or stones within her conduit.The patient was discharged in stable condition.

Event Description

It was reported to boston scientific corporation that an obtryx halo system device was implanted into the patient during a procedure performed on june 23, 2010.As reported by the patient's attorney, the patient experienced an unspecified injury.Additional information received on january 14, 2022: on june 23, 2010, a hysterectomy was performed prior to the sling placement.The operative report for the obtryx implant notes that on the patient's left side, there was some perforation of the skin lateral to the vaginal incision on the left which was recognized, and the needle was placed beneath this.Cystoscopy was performed and the operative report states the patient had some methylene blue which made visualization a bit difficult.There was some redundant vaginal mucosa along the left trigone.The remainder of the bladder was free of any lesions, stones, or foreign bodies.On (b)(6) 2010, the patient presented with recurrent urinary tract infections utis that seemed worse since the obtryx surgery.One uti had been associated with fever and low blood pressure and had developed while she was on macrobid.The patient also had hesitancy and incomplete emptying.She denied any leakage.Urinalysis was performed and culture was submitted.Post void residual pvr via bladder scan was 147 ml.The assessment included chronic cystitis and incomplete bladder emptying.The plan was for the patient to continue macrobid, and undergo uroflow, cystourethroscopy, and cystogram.It was noted that the sling may need to be incised if the recurrent utis could not be controlled.On (b)(6) 2015, the patient presented for evaluation of urinary retention.She reported no pain and no leakage.She denied constipation, dysuria, fever, urinary frequency, hematuria, and history of diabetes.She had been self-catheterizing 6 times per day for 2 years with minimal voiding in between.The visit notes indicate the patient had undergone cystogram in (b)(6) 2010 which showed incomplete emptying, but she never did any follow up.In 2012, cystometrogram showed the patient was without desire and 600 cc was drained.The patient had undergone an unspecified number of cystoscopies.The patient had intermittent utis.Genitourinary exam revealed no abnormalities.The medical record notes that possibly sling was obstructive and has slowly damaged bladder over the years and now does clean intermittent catheterization cic.The patient declined further evaluation at this time and noted she would call the physician if needed.On (b)(6) 2020, the patient presented for second opinion regarding vaginal mesh erosion and recurrent utis.She has a longstanding history of a neurogenic bladder and interstitial cystitis.She underwent an ileal conduit and simple versus radical cystectomy and urethral sling removal in (b)(6) 2018.However, the patient reported remnant of the mesh in her vagina.Furthermore, the patient reported the following during the visit: dyspareunia; vaginal bleeding postcoital; symptomatic with the recurrent utis including flank pain, chills, nausea, and purulent drainage from her urostomy.She had been on multiple rounds of antibiotics; improvement on her cystitis post cystectomy and conduit.Physical exam noted the ileal conduit with a healthy-appearing stoma, clear urine in the urostomy bag, and a small fragment of eroded vaginal mesh at the left apex of the vagina.The assessments were as follows: 1.Neurogenic bladder status post heal conduit (b)(6) 2018.2.Recurrent utis postoperatively.3.Dyspareunia secondary to eroded vaginal mesh.4.History of interstitial cystitis.5.Neurogenic bowel.The patient was advised regarding her dyspareunia and eroded vaginal mesh that options included doing nothing versus removal if she is symptomatic.The patient wanted to have her eroded vaginal mesh removed as intercourse was painful.The patient was advised that with her history of interstitial cystitis and multiple pelvic surgeries that she may continue to have dyspareunia and/or pain post mesh removal.We also discussed that repeat surgeries can lead to recurrent scar tissue and increased pain.On (b)(6) 2020, the patient presented due to erosion of implanted vaginal mesh to surrounding organ/tissue and underwent an excision of eroded vaginal mesh; transvaginal enterocele repair; looposcopy and sling removal.Her postoperative diagnoses included erosion of implanted vaginal mesh to surrounding organ/tissue and enterocele.Additionally, findings during the procedure included: 1.Eroded mesh seen along the left suburethral region extending toward the left endopelvic fascia.2.Atrophic.3.Peritoneum was seen extruding through the vagina and the suburethral mesh was adherent to the peritoneum and vagina.The peritoneum was separated off the vaginal wall.However, the mesh was adherent to the peritoneum and both the mesh and peritoneum were excised in their entirety in the suburethral region extending to the left endopelvic fascia.4.The enterocele was reduced and the peritoneum closed using 3-0 vicryl.5.The remnants of mesh at the left endopelvic fascia were placed on traction and excised in entirety.There is no visible mesh seen at this time.6.Her ileal conduit had a healthy stoma and there were no foreign bodies or stones within her conduit.Additional information received on september 20, 2022: office visit on may 12, 2020: the patient came for vaginal check.She presented to rule out uti and for postop follow up.She had history of utis with back pain and just ended the course of macrobid.On (b)(6) 2020, she had pap smear within normal limits.Positive for weight gain and recently started back on lupus meds.Patient felt confident that she currently has uti.No history of temps but never gets temps only back pain and chills over past 3-4 days reported.Positive sino-atrial; staph aureus sa since surgery last week, some left sided dyspareunia but not as bad as preoperatively.Annual health update: experiencing pain with sex: yes.Have to urinate too frequently during the day or night: yes, 5 times in an 8-hour period.Your weight has: increased.Pelvic pain: yes - lower right quadrant; pain scale is 3/10 and 10/10 being the worst pain possible.Experiencing problems with abnormal vaginal discharge: yes.Review of systems: respiratory: she admits to asthma or wheezing.Cardiovascular: she admits to history or heart murmur and sudden heartbeat changes.Gastrointestinal: she admits to frequent diarrhea and change in bowel movements.Genitourinary: she admits to blood in urine.Gynecological: patient admits to hot flashes/night sweats.Skin/breasts: she admits to rash or itching and change in hair or nails.Musculoskeletal: she admits to joint pain, muscle pain or cramps, weakness of muscles or joints, back pain and cold extremities.Neurological: she admits to convulsions or seizures, lightheaded or dizzy, numbness or tingling sensation and tremors.Psychiatric: she admits to depression and memory loss or confusion.Endocrine: she admits to diabetes, thyroid disease, heat or cold intolerance, dry skin and excessive thirst or urination.Hematologic and lymphatic: she admits slow to heal after cuts and easily bruise or bleed.Examination: respiratory: normal breath sounds are heard bilaterally.There is no wheezing.Cardiovascular: no murmurs, rubs or gallops, with normal rate and rhythm.Skin: no significant skin changes are noted.Back: exam showed full range of motion.No spasm or tenderness was noted.Straight leg raising was negative bilaterally.No cvat.Pelvic: mild to moderate tenderness over bladder wall on vaginal exam.Vagina: vagina well healed, moderate cystocele, small enterocele, small rectocele, moderate vaginal atrophy.Impression/diagnosis: abnormal weight gain, cystocele, unspecified, dyspareunia and enterocele, vaginal, microscopic hematuria, obesity and rectocele.Spr, urinary tract infection, vaginitis, postmenopausal atrophic and vaginits, subacute/chronic.Niddm non-insulin dependent diabetes mellitus.Medications prescribed: gentamicin 40 mg/ml, take 1 ml intramuscular inject as directed.Gent 100 mg/bring to office for injection.Dispense 2.Refills 0.Diet and exercise lit given and reviewed today.Progress note dated february 15, 2021: patient came with chief complaint of pudendal and obturator neuralgia.In march of 2020 she had the vaginal portion of the mesh removed with no change in pain.Patient presents for physical examination and to discuss treatment options going forward.Discussed removing whenever retained vaginal mesh is present as well as bilateral groin exploration for mesh excision.Physical exam: 1.General: overweight middle-aged female appears uncomfortable favoring her left side.2.Abdomen: soft, flat, no masses palpated, no hernias noted, positive tenderness associated with the left portion of her pfannenstiel scar consistent with ilioinguinal neuralgia, ileal conduit stoma healthy and functional.3.Vagina: the levator plate is moderately tender to palpation, a segment of mesh could be palpable on both inferior pubic rami, the left appears more prominent than the right, the areas are exquisitely tender, the obturator internus muscle is tender bilaterally 4.Cervix: surgically absent.5.Rectal: both sacrospinous ligament complexes are tender to palpation with a positive tinel sign.Impression: the patient has postoperative obturator and pudendal neuralgia also with evidence of left-sided ilioinguinal neuralgia.Plan: after careful consideration the patient wishes to proceed with total mesh excision.Also, we will perform a left-sided ilioinguinal/iliohypogastric neurectomy.Visit diagnosis: dyspareunia in female - primary.Postoperative obturator neuralgia.Pudendal neuralgia.Office visit on (b)(6) 2021: the patient has opted to proceed with total mesh excision including the remainders of the mesh vaginally as well as a bilateral groin exploration for mesh excision.She also wants to proceed with a left-sided ilioinguinal/iliohypogastric neurectomy.Procedures scheduled on march 11, 2021.Additionally, the patient was reported to be allergic to cephalosporins, fentanyl, lamictal, sulfa, vancomycin.Mesh excision on (b)(6) 2021: preoperatively, the patient was diagnosed with pudendal neuralgia, obturator neuralgia, left-sided ilioinguinal neuralgia, and dyspareunia.On palpation, appeared to be a significant piece of mesh palpable on the left anterior fornix of the vagina, which corresponded to her preoperative examination of an area of exquisite tenderness.On the right findings were much more subtle, possibly just consistent with scar tissue.Piece of mesh on the right, left and groin were identified and dissected and saved for pathology.The patient was awakened in the operating room, brought to recovery room awake, alert, in apparent stable condition.Postoperatively, a segment of mesh was retrieved from the left anterior lateral vaginal compartment with no mesh retrieved on the right, large piece of mesh retrieved from both groin dissections, it would appear all the mesh was removed.Final pathological diagnosis: 1.Left ilioinguinal nerve: fibroadipose tissue with large nerve fibers, and adjacent skeletal muscle.2.Bilateral groin and vaginal mesh: fibromuscular and adipose tissue with chronic inflammation, multinucleated giant cell reaction, and foreign body consistent with mesh.Fragment of squamous mucosa with hemorrhage.On (b)(6) 2021, patient came into the emergency room today with complaint of right flank pain and a right urostomy was not draining.She also had some low-grade fever.No chest pain shortness of breath.She was also noticed to be tachycardic and has low grade fever.On exam she is alert awake and oriented not in distress.Lungs clear.Abdomen is soft.Lleal conduit in place.Bilateral nephrostomy tube is now draining.Both lower extremity no edema.Plan patient will be kept under observation for sirs - systemic inflammatory response syndrome, she will be on iv hydration and supportive care.Case was discussed by er physician with infectious disease physician who recommended to hold off antibiotics unless she continues to spike fever or clear evidence of infection.Initial presentation for malfunctioning nephrostomy tube which spontaneously started working.Ct scan does not show any obvious blockage.Urology was consulted by er physician.Supportive care for now.Patient appears to have subconjunctival hemorrhage.Will use scds for dvt prophylaxis.Discharge diagnosis principal problem: obstructed nephrostomy tube cms/hcc.Active problems: hypertensive heart disease without heart failure, sle systemic lupus erythematosus related syndrome cms/hcc, recurrent uti, wound of left groin, retinal hemorrhage of both eyes, diabetes mellitus type 2 in obese cms/hcc, hypothyroid.Resolved problems: tachycardia.

Manufacturer Narrative

Blocks b5, b6, b7 and h6: patient codes have been updated based on the information received on september 20, 2022.Block b3: the exact event onset date is unknown; however, it was reported that the patient had a first office visit on (b)(6) 2010 due to symptoms.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Explant surgeons are: dr.(b)(6).Dr.(b)(6).Block h6: patient codes e2006, e1309, e2114, e1405, e232401, e2330, e1906, e1310, e2015, e0123, e2101, e1715, e1302, e1401, e2326 and e2401 capture the reportable events of erosion, urinary retention, perforation, dyspareunia, fecal incontinence, pain, unspecified infection, urinary tract injury, unspecified tissue injury, nerve damage and adhesion, hematuria, abnormal vaginal discharge, inflammation, and wound of left groin.Impact codes f1901 and f1903 capture the reportable events of surgical intervention and mesh removal.Block 11: g2 report source has been corrected.

Event Description

It was reported to boston scientific corporation that an obtryx halo system device was implanted into the patient during a procedure performed on (b)(6), 2010.As reported by the patient's attorney, the patient experienced an unspecified injury.Additional information received on january 14, 2022: on (b)(6), 2010, a hysterectomy was performed prior to the sling placement.The operative report for the obtryx implant notes that on the patient's left side, there was some perforation of the skin lateral to the vaginal incision on the left which was recognized, and the needle was placed beneath this.Cystoscopy was performed and the operative report states the patient had some methylene blue which made visualization a bit difficult.There was some redundant vaginal mucosa along the left trigone.The remainder of the bladder was free of any lesions, stones, or foreign bodies.On (b)(6), 2010, the patient presented with recurrent urinary tract infections utis that seemed worse since the obtryx surgery.One uti had been associated with fever and low blood pressure and had developed while she was on macrobid.The patient also had hesitancy and incomplete emptying.She denied any leakage.Urinalysis was performed and culture was submitted.Post void residual pvr via bladder scan was 147 ml.The assessment included chronic cystitis and incomplete bladder emptying.The plan was for the patient to continue macrobid, and undergo uroflow, cystourethroscopy, and cystogram.It was noted that the sling may need to be incised if the recurrent utis could not be controlled.On (b)(6), 2015, the patient presented for evaluation of urinary retention.She reported no pain and no leakage.She denied constipation, dysuria, fever, urinary frequency, hematuria, and history of diabetes.She had been self-catheterizing 6 times per day for 2 years with minimal voiding in between.The visit notes indicate the patient had undergone cystogram in (b)(6) 2010 which showed incomplete emptying, but she never did any follow up.In 2012, cystometrogram showed the patient was without desire and 600 cc was drained.The patient had undergone an unspecified number of cystoscopies.The patient had intermittent utis.Genitourinary exam revealed no abnormalities.The medical record notes that possibly sling was obstructive and has slowly damaged bladder over the years and now does clean intermittent catheterization cic.The patient declined further evaluation at this time and noted she would call the physician if needed.On (b)(6), 2020, the patient presented for second opinion regarding vaginal mesh erosion and recurrent utis.She has a longstanding history of a neurogenic bladder and interstitial cystitis.She underwent an ileal conduit and simple versus radical cystectomy and urethral sling removal in (b)(6) 2018.However, the patient reported remnant of the mesh in her vagina.Furthermore, the patient reported the following during the visit: dyspareunia; vaginal bleeding postcoital; symptomatic with the recurrent utis including flank pain, chills, nausea, and purulent drainage from her urostomy.She had been on multiple rounds of antibiotics; improvement on her cystitis post cystectomy and conduit.Physical exam noted the ileal conduit with a healthy-appearing stoma, clear urine in the urostomy bag, and a small fragment of eroded vaginal mesh at the left apex of the vagina.The assessments were as follows: 1.Neurogenic bladder status post heal conduit (b)(6) 2018 2.Recurrent utis postoperatively 3.Dyspareunia secondary to eroded vaginal mesh 4.History of interstitial cystitis 5.Neurogenic bowel the patient was advised regarding her dyspareunia and eroded vaginal mesh that options included doing nothing versus removal if she is symptomatic.The patient wanted to have her eroded vaginal mesh removed as intercourse was painful.The patient was advised that with her history of interstitial cystitis and multiple pelvic surgeries that she may continue to have dyspareunia and/or pain post mesh removal.We also discussed that repeat surgeries can lead to recurrent scar tissue and increased pain.On (b)(6), 2020, the patient presented due to erosion of implanted vaginal mesh to surrounding organ/tissue and underwent an excision of eroded vaginal mesh; transvaginal enterocele repair; looposcopy and sling removal.Her postoperative diagnoses included erosion of implanted vaginal mesh to surrounding organ/tissue and enterocele.Additionally, findings during the procedure included: 1.Eroded mesh seen along the left suburethral region extending toward the left endopelvic fascia.2.Atrophic.3.Peritoneum was seen extruding through the vagina and the suburethral mesh was adherent to the peritoneum and vagina.The peritoneum was separated off the vaginal wall.However, the mesh was adherent to the peritoneum and both the mesh and peritoneum were excised in their entirety in the suburethral region extending to the left endopelvic fascia.4.The enterocele was reduced and the peritoneum closed using 3-0 vicryl.5.The remnants of mesh at the left endopelvic fascia were placed on traction and excised in entirety.There is no visible mesh seen at this time.6.Her ileal conduit had a healthy stoma and there were no foreign bodies or stones within her conduit.Additional information received on (b)(6), 2022 office visit on (b)(6), 2020: the patient came for vaginal check.She presented to rule out uti and for postop follow up.She had history of utis with back pain and just ended the course of macrobid.On (b)(6), 2020, she had pap smear within normal limits.Positive for weight gain and recently started back on lupus meds.Patient felt confident that she currently has uti.No history of temps but never gets temps only back pain and chills over past 3-4 days reported.Positive sino-atrial; staph aureus sa since surgery last week, some left sided dyspareunia but not as bad as preoperatively.Annual health update: experiencing pain with sex: yes have to urinate too frequently during the day or night: yes, 5 times in an 8-hour period.Your weight has: increased pelvic pain: yes - lower right quadrant; pain scale is 3/10 and 10/10 being the worst pain possible.Experiencing problems with abnormal vaginal discharge: yes review of systems respiratory: she admits to asthma or wheezing.Cardiovascular: she admits to history or heart murmur and sudden heartbeat changes.Gastrointestinal: she admits to frequent diarrhea and change in bowel movements.Genitourinary: she admits to blood in urine.Gynecological: patient admits to hot flashes/night sweats.Skin/breasts: she admits to rash or itching and change in hair or nails.Musculoskeletal: she admits to joint pain, muscle pain or cramps, weakness of muscles or joints, back pain and cold extremities.Neurological: she admits to convulsions or seizures, lightheaded or dizzy, numbness or tingling sensation and tremors.Psychiatric: she admits to depression and memory loss or confusion.Endocrine: she admits to diabetes, thyroid disease, heat or cold intolerance, dry skin and excessive thirst or urination.Hematologic and lymphatic: she admits slow to heal after cuts and easily bruise or bleed.Examination respiratory: normal breath sounds are heard bilaterally.There is no wheezing.Cardiovascular: no murmurs, rubs or gallops, with normal rate and rhythm.Skin: no significant skin changes are noted.Back: exam showed full range of motion.No spasm or tenderness was noted.Straight leg raising was negative bilaterally.No cvat.Pelvic: mild to moderate tenderness over bladder wall on vaginal exam.Vagina: vagina well healed moderate cystocele small enterocele small rectocele moderate vaginal atrophy impression/diagnosis: abnormal weight gain, cystocele, unspecified, dyspareunia and enterocele, vaginal, microscopic hematuria, obesity and rectocele.Spr, urinary tract infection, vaginitis, postmenopausal atrophic and vaginits, subacute/chronic.Niddm non-insulin dependent diabetes mellitus.Medications prescribed: gentamicin 40 mg/ml, take 1 ml intramuscular inject as directed.Gent 100 mg/bring to office for injection dispense 2 refills 0 diet and exercise lit given and reviewed today progress note dated (b)(6) 2021: patient came with chief complaint of pudendal and obturator neuralgia.In (b)(6) of 2020 she had the vaginal portion of the mesh removed with no change in pain.Patient presents for physical examination and to discuss treatment options going forward.Discussed removing whenever retained vaginal mesh is present as well as bilateral groin exploration for mesh excision.Physical exam 1.General: overweight middle-aged female appears uncomfortable favoring her left side.2.Abdomen: soft, flat, no masses palpated, no hernias noted, positive tenderness associated with the left portion of her pfannenstiel scar consistent with ilioinguinal neuralgia, ileal conduit stoma healthy and functional.3.Vagina: the levator plate is moderately tender to palpation, a segment of mesh could be palpable on both inferior pubic rami, the left appears more prominent than the right, the areas are exquisitely tender, the obturator internus muscle is tender bilaterally 4.Cervix: surgically absent 5.Rectal: both sacrospinous ligament complexes are tender to palpation with a positive tinel sign.Impression: the patient has postoperative obturator and pudendal neuralgia also with evidence of left-sided ilioinguinal neuralgia.Plan: after careful consideration the patient wishes to proceed with total mesh excision.Also, we will perform a left-sided ilioinguinal/iliohypogastric neurectomy.Visit diagnosis: dyspareunia in female - primary postoperative obturator neuralgia pudendal neuralgia office visit on (b)(6), 2021: the patient has opted to proceed with total mesh excision including the remainders of the mesh vaginally as well as a bilateral groin exploration for mesh excision.She also wants to proceed with a left-sided ilioinguinal/iliohypogastric neurectomy.Procedures scheduled on (b)(6) 2021.Additionally, the patient was reported to be allergic to cephalosporins, fentanyl, lamictal, sulfa, vancomycin.Mesh excision on (b)(6), 2021: preoperatively, the patient was diagnosed with pudendal neuralgia, obturator neuralgia, left-sided ilioinguinal neuralgia, and dyspareunia.On palpation, appeared to be a significant piece of mesh palpable on the left anterior fornix of the vagina, which corresponded to her preoperative examination of an area of exquisite tenderness.On the right findings were much more subtle, possibly just consistent with scar tissue.Piece of mesh on the right, left and groin were identified and dissected and saved for pathology.The patient was awakened in the operating room, brought to recovery room awake, alert, in apparent stable condition.Postoperatively, a segment of mesh was retrieved from the left anterior lateral vaginal compartment with no mesh retrieved on the right, large piece of mesh retrieved from both groin dissections, it would appear all the mesh was removed.Final pathological diagnosis: 1.Left ilioinguinal nerve -fibroadipose tissue with large nerve fibers, and adjacent skeletal muscle.2.Bilateral groin and vaginal mesh: -fibromuscular and adipose tissue with chronic inflammation, multinucleated giant cell reaction, and foreign body consistent with mesh.-fragment of squamous mucosa with hemorrhage.On (b)(6), 2021, patient came into the emergency room today with complaint of right flank pain and a right urostomy was not draining.She also had some low-grade fever.No chest pain shortness of breath.She was also noticed to be tachycardic and has low grade fever.On exam she is alert awake and oriented not in distress.Lungs clear.Abdomen is soft.Lleal conduit in place.Bilateral nephrostomy tube is now draining.Both lower extremity no edema.Plan patient will be kept under observation for sirs - systemic inflammatory response syndrome, she will be on iv hydration and supportive care.Case was discussed by er physician with infectious disease physician who recommended to hold off antibiotics unless she continues to spike fever or clear evidence of infection.Initial presentation for malfunctioning nephrostomy tube which spontaneously started working.Ct scan does not show any obvious blockage.Urology was consulted by er physician.Supportive care for now.Patient appears to have subconjunctival hemorrhage.Will use scds for dvt prophylaxis.Discharge diagnosis principal problem: obstructed nephrostomy tube cms/hcc active problems: hypertensive heart disease without heart failure sle systemic lupus erythematosus related syndrome cms/hcc recurrent uti wound of left groin retinal hemorrhage of both eyes diabetes mellitus type 2 in obese cms/hcc hypothyroid resolved problems: tachycardia additional information received on october 13, 2022; on (b)(6), 2017, patient came for urological evaluation.She stated that frequency symptoms had not changed.She always had pain or burning with urination.She had a history of frequent uti.Urgency symptoms had not changed.She had been treated with oral medications.Medications tried for bladder symptoms are elmiron instillations.She was diagnosed with interstitial cystitis by cysto and had to undergo weekly elmiron instillations.The most bothersome urinary compliant is burning and problems going.On (b)(6) 2016, she developed uti.Her urine looks clear today.She had been having a lot of bladder pain and lower abdominal pain.Catheter also hurt.Last year, patient saw a physician and ordered urodynamics which demonstrated a large capacity bladder with no sensation or urge at 750ccs but with staccato like d.O., good compliance.Patient also had a history of cyclophosphamide use.She had a recent uti and pyelonephritis status post treatment with cipro three weeks ago and iv levaquin for two weeks total.Issues with diarrhea.Her post void residual today is 283.She did not get an improvement with elavil, and she is getting elmiron per bladder to avoid interactions with her other medications.She had been stable for a year on this regimen.She said she never emptied her bladder and was willing to cic, clean intermittent catheterization.However, on (b)(6), 2013, she had been unable to cic and it was giving her flank pain.Her follow up renal ultrasound on (b)(6), 2013 demonstrated resolution of her previous right hydronephrosis.She was only on catheter twice daily, had a uti currently and still had left flank pain with a full bladder.On (b)(6), 2014, her renal ultrasound is negative for hydronephrosis but demonstrated a right renal stone x1.Had been doing cics per day and sometimes got large amounts of urine out and had less back/side pain and less fullness in her right pelvis.She noticed that her pain improved with the increase in the number of cics.Renal ultrasound performed again on (b)(6), 2014 and still no hydro visible.On (b)(6), 2016, her cysto demonstrated severe stenosis status post dilation.Exam revealed moderate atrophy peri-urethrally, a grade 1 cystocele.On (b)(6), 2017, estrace discontinued due to blood clot risk.Genito-urinary past medical history: urethral stricture, unspecified (urethral stricture) - (b)(6) 2016 dysuria - (b)(6) 2016 & (b)(6) 2014 urinary retention - (b)(6) 2014 incomplete bladder emptying - 2013.

Manufacturer Narrative

Blocks b5, b7 and h6: patient codes have been updated based on the information received on october 13, 2022.Block b3: the exact event onset date is unknown; however, it was reported that the patient had a first office visit on (b)(6), 2010 due to symptoms.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6).Explant surgeons are: *dr.(b)(6).*dr.(b)(6).(b)(6).Block h6: patient codes e2006, e1309, e2114, e1405, e232401, e2330, e1906, e1310, e2015, e0123, e2101, e1715, e1302, e1401, e2326, e2401, e2337 and e1301 capture the reportable events of erosion, urinary retention, perforation, dyspareunia, fecal incontinence, pain, unspecified infection, urinary tract injury, unspecified tissue injury, nerve damage and adhesion, hematuria, abnormal vaginal discharge, inflammation, and wound of left groin, urethral stricture and severe stenosis, and dysuria.Impact codes f1901 and f1903 capture the reportable events of surgical intervention and mesh removal.

Manufacturer Narrative

Blocks b5, b6 and h6 patient codes and impact codes have been updated, based on the additional information received on (b)(6) 2022.Block b3: the exact event onset date is unknown.However, it was reported, that the patient had a first office visit on (b)(6) 2010, due to symptoms.Block e1: this event was reported, by the patient's legal representation.The implant surgeon is: dr.(b)(6).Explant surgeons are: dr.(b)(6).Block h6: patient codes e2006, e1309, e2114, e1405, e232401, e2330, e1906, e1310, e2015, e0123, e2101, e1715, e1302, e1401, e2326, e2401, e2337, e1301 and e172001 capture the reportable events of erosion, urinary retention, perforation, dyspareunia, fecal incontinence, pain, unspecified infection, urinary tract injury, unspecified tissue injury, nerve damage and adhesion, hematuria, abnormal vaginal discharge, inflammation, and wound of left groin, urethral stricture and severe stenosis, dysuria and abscess.Impact codes f1901, f1903 and f1202 capture the reportable events of surgical intervention, mesh removal and abscess.

Event Description

It was reported, to boston scientific corporation.That an obtryx halo system device was implanted into the patient, during a procedure performed on (b)(6) 2010.As reported, by the patient's attorney.The patient experienced an unspecified injury.Additional information received on (b)(6) 2022: on (b)(6) 2010, a hysterectomy was performed, prior to the sling placement.The operative report for the obtryx implant notes, that on the patient's left side, there was some perforation of the skin lateral to the vaginal incision on the left, which was recognized.And the needle was placed beneath this.Cystoscopy was performed and the operative report states, the patient had some methylene blue, which made visualization a bit difficult.There was some redundant vaginal mucosa along the left trigone.The remainder of the bladder was free of any lesions, stones, or foreign bodies.On (b)(6) 2010, the patient presented with recurrent urinary tract infections utis that seemed worse since the obtryx surgery.One uti had been associated with fever and low blood pressure.And had developed, while she was on macrobid.The patient also, had hesitancy and incomplete emptying.She denied any leakage.Urinalysis was performed and culture was submitted.Post void residual pvr via bladder scan was 147 ml.The assessment included chronic cystitis and incomplete bladder emptying.The plan was for the patient to continue macrobid, and undergo uroflow, cystourethroscopy, and cystogram.It was noted, that the sling may need to be incised if the recurrent utis could not be controlled.On (b)(6) 2015, the patient presented for evaluation of urinary retention.She reported, no pain and no leakage.She denied constipation, dysuria, fever, urinary frequency, hematuria, and history of diabetes.She had been self catheterizing (b)(6) times, per day for 2 years with minimal voiding in between.The visit notes, indicate the patient had undergone cystogram in (b)(6) 2010, which showed incomplete emptying, but she never did any follow up.In 2012, cystometrogram showed, the patient was without desire and 600 cc was drained.The patient had undergone an unspecified number of cystoscopies.The patient had intermittent utis.Genitourinary exam revealed, no abnormalities.The medical record notes, that possibly sling was obstructive and has slowly damaged bladder over the years.And now does clean intermittent catheterization cic.The patient declined further evaluation at this time.And noted, she would call the physician if needed.On (b)(6) 2020, the patient presented for second opinion regarding vaginal mesh erosion and recurrent utis.She has a longstanding history of a neurogenic bladder and interstitial cystitis.She underwent an ileal conduit and simple versus radical cystectomy and urethral sling removal in (b)(6) 2018.However, the patient reported, remnant of the mesh in her vagina.Furthermore, the patient reported, the following during the visit: dyspareunia, vaginal bleeding postcoital, symptomatic with the recurrent utis including flank pain, chills, nausea, and purulent drainage from her urostomy.She had been on multiple rounds of antibiotics.Improvement on her cystitis post cystectomy and conduit.Physical exam noted, the ileal conduit with a healthy appearing stoma, clear urine in the urostomy bag, and a small fragment of eroded vaginal mesh at the left apex of the vagina.The assessments were as follows: 1.Neurogenic bladder status post heal conduit (b)(6) 2018.2.Recurrent utis postoperatively.3.Dyspareunia secondary to eroded vaginal mesh.4.History of interstitial cystitis.5.Neurogenic bowel.The patient was advised regarding her dyspareunia and eroded vaginal mesh, that options included doing nothing versus removal if she is symptomatic.The patient wanted to have her eroded vaginal mesh removed as intercourse was painful.The patient was advised, that with her history of interstitial cystitis and multiple pelvic surgeries that she may continue to have dyspareunia and/or pain post mesh removal.We also discussed, that repeat surgeries can lead to recurrent scar tissue and increased pain.On (b)(6) 2020, the patient presented, due to erosion of implanted vaginal mesh to surrounding organ/tissue and underwent an excision of eroded vaginal mesh, transvaginal enterocele repair, looposcopy and sling removal.Her postoperative diagnoses included erosion of implanted vaginal mesh to surrounding organ/tissue and enterocele.Additionally, findings during the procedure included: 1.Eroded mesh seen along the left suburethral region extending toward the left endopelvic fascia.2.Atrophic.3.Peritoneum was seen extruding through the vagina and the suburethral mesh was adherent to the peritoneum and vagina.The peritoneum was separated off the vaginal wall.However, the mesh was adherent to the peritoneum and both the mesh and peritoneum were excised in their entirety in the suburethral region extending to the left endopelvic fascia.4.The enterocele was reduced and the peritoneum closed using 3 - 0 vicryl.5.The remnants of mesh at the left endopelvic fascia were placed on traction and excised in entirety.There is no visible mesh seen at this time.6.Her ileal conduit had a healthy stoma.And there were no foreign bodies or stones within her conduit.Additional information received, on (b)(6) 2022 office visit on (b)(6) 2020: the patient came for vaginal check.She presented to rule out uti and for postop follow up.She had history of utis with back pain and just ended the course of macrobid.On (b)(6) 2020, she had pap smear within normal limits.Positive for weight gain and recently started back on lupus meds.Patient felt confident that she currently has uti.No history of temps, but never gets temps only back pain and chills over past (b)(6) days reported.Positive sino - atrial, staph aureus sa, since surgery last week.Some left sided dyspareunia, but not as bad as preoperatively.Annual health update: experiencing pain with sex? yes.Have to urinate too frequently during the day or night? yes, 5 times in an 8 - hour period.Your weight has? increased.Pelvic pain? yes, lower right quadrant.Pain scale is 3/10 and 10/10 being the worst pain possible.Experiencing problems with abnormal vaginal discharge? yes.Review of systems: respiratory: she admits to asthma or wheezing.Cardiovascular: she admits to history or heart murmur and sudden heartbeat changes.Gastrointestinal: she admits to frequent diarrhea and change in bowel movements.Genitourinary: she admits to blood in urine.Gynecological: patient admits to hot flashes/night sweats.Skin/breasts: she admits to rash or itching and change in hair or nails.Musculoskeletal: she admits to joint pain, muscle pain or cramps, weakness of muscles or joints, back pain and cold extremities.Neurological: she admits to convulsions or seizures, lightheaded or dizzy, numbness or tingling sensation and tremors.Psychiatric: she admits to depression and memory loss or confusion.Endocrine: she admits to diabetes, thyroid disease, heat or cold intolerance, dry skin and excessive thirst or urination.Hematologic and lymphatic: she admits slow to heal after cuts and easily bruise or bleed.Examination: respiratory: normal breath sounds are heard bilaterally.There is no wheezing.Cardiovascular: no murmurs, rubs or gallops, with normal rate and rhythm.Skin: no significant skin changes are noted.Back: exam showed full range of motion.No spasm or tenderness was noted.Straight leg raising was negative bilaterally.No cvat.Pelvic: mild to moderate tenderness over bladder wall on vaginal exam.Vagina: vagina well healed.Moderate cystocele, small enterocele, small rectocele, moderate vaginal atrophy.Impression/diagnosis: abnormal weight gain, cystocele, unspecified, dyspareunia and enterocele, vaginal, microscopic hematuria, obesity and rectocele, spr, urinary tract infection, vaginitis, postmenopausal atrophic and vaginits, subacute/chronic, niddm non - insulin dependent diabetes mellitus.Medications prescribed: gentamicin 40 mg/ml, take 1 ml intramuscular inject as directed, gent 100 mg/bring to office for injection.Dispense 2.Refills 0.Diet and exercise lit given and reviewed today.Progress note, dated (b)(6) 2021: patient came with chief complaint of pudendal and obturator neuralgia.In (b)(6) of 2020, she had the vaginal portion of the mesh removed with no change in pain.Patient presents for physical examination and to discuss treatment options going forward.Discussed removing, whenever retained vaginal mesh is present, as well as bilateral groin exploration for mesh excision.Physical exam: 1.General: overweight middle, aged female appears uncomfortable favoring her left side.2.Abdomen: soft, flat, no masses palpated, no hernias noted, positive tenderness associated with the left portion of her pfannenstiel scar consistent with ilioinguinal neuralgia, ileal conduit stoma healthy and functional.3.Vagina: the levator plate is moderately tender to palpation, a segment of mesh could be palpable on both inferior pubic rami, the left appears more prominent than the right, the areas are exquisitely tender, the obturator internus muscle is tender bilaterally.4.Cervix: surgically absent.5.Rectal: both sacrospinous ligament complexes are tender to palpation with a positive tinel sign.Impression: the patient has postoperative obturator and pudendal neuralgia.Also with evidence of left sided ilioinguinal neuralgia.Plan: after careful consideration, the patient wishes to proceed with total mesh excision.Also, we will perform a left sided ilioinguinal/iliohypogastric neurectomy.Visit diagnosis: dyspareunia in female, primary postoperative obturator neuralgia, pudendal neuralgia.Office visit on (b)(6) 2021: the patient has opted to proceed with total mesh excision.Including the remainders of the mesh vaginally, as well as a bilateral groin exploration for mesh excision.She also, wants to proceed with a left sided ilioinguinal/iliohypogastric neurectomy.Procedures scheduled on (b)(6) 2021.Additionally, the patient was reported, to be allergic to cephalosporins, fentanyl, lamictal, sulfa, vancomycin.Mesh excision on (b)(6) 2021: preoperatively, the patient was diagnosed with pudendal neuralgia, obturator neuralgia, left sided ilioinguinal neuralgia, and dyspareunia.On palpation, appeared to be a significant piece of mesh palpable on the left anterior fornix of the vagina, which corresponded to her preoperative examination of an area of exquisite tenderness.On the right findings were much more subtle, possibly just consistent with scar tissue.Piece of mesh on the right, left and groin were identified and dissected and saved for pathology.The patient was awakened in the operating room, brought to recovery room awake, alert, in apparent stable condition.Postoperatively: a segment of mesh was retrieved from the left anterior lateral vaginal compartment with no mesh retrieved on the right, large piece of mesh retrieved from both groin dissections.It would appear all the mesh was removed.Final pathological diagnosis: 1.Left ilioinguinal nerve: fibroadipose tissue with large nerve fibers, and adjacent skeletal muscle.2.Bilateral groin and vaginal mesh: fibromuscular and adipose tissue with chronic inflammation, multinucleated giant cell reaction, and foreign body consistent with mesh.Fragment of squamous mucosa with hemorrhage.On (b)(6) 2021, patient came into the emergency room today with complaint of right flank pain and a right urostomy was not draining.She also had some low grade fever.No chest pain shortness of breath.She was also noticed, to be tachycardic and has low grade fever.On exam she is alert awake and oriented not in distress.Lungs clear.Abdomen is soft.Lleal conduit in place.Bilateral nephrostomy tube is now draining.Both lower extremity no edema.Plan patient will be kept under observation for sirs systemic inflammatory response syndrome.She will be on iv hydration and supportive care.Case was discussed by er physician with infectious disease physician who recommended to hold off antibiotics unless she continues to spike fever or clear evidence of infection.Initial presentation for malfunctioning nephrostomy tube, which spontaneously started working.Ct scan does not show any obvious blockage.Urology was consulted by er physician.Supportive care for now.Patient appears to have subconjunctival hemorrhage.Will use scds for dvt prophylaxis.Discharge diagnosis: principal problem: obstructed nephrostomy tube cms/hcc.Active problems: hypertensive heart disease without heart failure, sle systemic lupus erythematosus related syndrome cms/hcc, recurrent uti, wound of left groin, retinal hemorrhage of both eyes, diabetes mellitus type 2 in obese cms/hcc, hypothyroid.Resolved problems: tachycardia.Additional information received, on (b)(6) 2022 on (b)(6) 2017, patient came for urological evaluation.She stated, that frequency symptoms had not changed.She always had pain or burning with urination.She had a history of frequent uti.Urgency symptoms had not changed.She had been treated with oral medications.Medications tried for bladder symptoms are elmiron instillations.She was diagnosed with interstitial cystitis by cysto.And had to undergo weekly elmiron instillations.The most bothersome urinary compliant is burning and problems going.On (b)(6) 2016, she developed uti.Her urine looks clear today.She had been having a lot of bladder pain and lower abdominal pain.Catheter also hurt.Last year, patient saw a physician and ordered urodynamics, which demonstrated a large capacity bladder with no sensation or urge at 750ccs, but with staccato like d.O., good compliance.Patient also, had a history of cyclophosphamide use.She had a recent uti and pyelonephritis status post treatment with cipro three weeks ago and iv levaquin for two weeks total.Issues with diarrhea.Her post void residual today is 283.She did not get an improvement with elavil, and she is getting elmiron per bladder to avoid interactions with her other medications.She had been stable for a year on this regimen.She said, she never emptied her bladder and was willing to cic, clean intermittent catheterization.However, on (b)(6) 2013, she had been unable to cic and it was giving her flank pain.Her follow up renal ultrasound on (b)(6) 2013, demonstrated resolution of her previous right hydronephrosis.She was only on catheter (b)(6) daily, had a uti currently, and still had left flank pain with a full bladder.On (b)(6) 2014, her renal ultrasound is negative for hydronephrosis, but demonstrated a right renal stone x1.Had been doing cics per day.And sometimes got large amounts of urine out and had less back/side pain and less fullness in her right pelvis.She noticed, that her pain improved with the increase in the number of cics.Renal ultrasound performed again on (b)(6) 2014 and still no hydro visible.On (b)(6) 2016, her cysto demonstrated severe stenosis status post dilation.Exam revealed, moderate atrophy peri urethrally, a grade 1 cystocele.On (b)(6) 2017, estrace discontinued, due to blood clot risk.Genito urinary past medical history: urethral stricture, unspecified (urethral stricture) (b)(6) 2016, dysuria (b)(6) 2016 & (b)(6) 2014, urinary retention (b)(6) 2014, incomplete bladder emptying - 2013.Additional information received, on (b)(6) 2022.On (b)(6) 2020, the patient came for urological evaluation for urinary symptoms.It was reported, that on (b)(6) 2017, pelvic pain and pain with intercourse is improved with physiotherapy, but still having pain when cathing, and incontinence.She was status post perc test on (b)(6) 2017.She had the best response on the left and was able to urinate on her own.Patient did clean intermittent catheterization with each side, and it helped with her bowel movement.She wanted to proceed with the permanent procedure.Patient stated, the hyoscyamine was no longer helping her bladder pain.On (b)(6) 2017, status post interstim placement and it helped her symptoms.Continued to cath (b)(6) times daily.Her pain is well controlled, but still required pain meds at night.Her incision was well healed.On (b)(6) 2017, she was doing well post interstim.Her clean intermittent catheterization was down to (b)(6) per day.She got the highest residuals at night.Her pain was improved, but not gone away.On (b)(6) 2018, her sample urine is very dark yellow.Continued to have left flank pain, that was improved with cathing.Urinary diversion versus botox was discussed, as the patient was very frustrated.On (b)(6) 2019, the patient was status post urinary diversion.Complicated post operation by sepsis.Had treated for presumed utis since.These have been relatively asymptomatic and related to colonization.Some left renal colic.Ct stone did not demonstrate anything that should be causing pain.No hydro/hernias.During a visit on (b)(6) 2013, the patient was complaining of blood in urine and microhematuria was found on urinalysis after the treatment for uti.She was then status post negative microhematuria workup.On (b)(6) 2020, patient came for a follow up through synchronous audio and video technology.She presented with complicated uti.Ciprofloxacin medicine was ordered for (b)(6) more days, and it was likely, that the patient was going to have a prolonged antibiotic therapy.There was also, a possible clostridium difficile complication.Patient was having fevers likely, due to reclast, if worsened she was advised to go to the er.It was also stated, that her urine was clearer, had ran temperature of 102 all night.She just had a procedure done a day before.In history, it was stated, that patient has been on multiple antibiotics for recurrent urinary tract infection.She had enterococcus faecalis, klebsiella oxytoca isolated in her urine cultures.Patient reported, that she felt somewhat better after taking antibiotics, but then had pus coming out of urostomy bag a few days later.During a follow up on (b)(6) 2021, it was stated, that the patient had finished iv daptomycin and peripherally inserted central catheter had been removed.Additionally, the patient answered a questionnaire stating, that she was entitled to medicare ,based on disability.New or worsening symptoms of fatigue.

Event Description

It was reported to boston scientific corporation that an obtryx halo system device was implanted into the patient during a procedure performed on (b)(6)2010.As reported by the patient's attorney, the patient experienced an unspecified injury.Additional information received on january 14, 2022: on (b)(6)2010, a hysterectomy was performed prior to the sling placement.The operative report for the obtryx implant notes that on the patient's left side, there was some perforation of the skin lateral to the vaginal incision on the left which was recognized, and the needle was placed beneath this.Cystoscopy was performed and the operative report states the patient had some methylene blue which made visualization a bit difficult.There was some redundant vaginal mucosa along the left trigone.The remainder of the bladder was free of any lesions, stones, or foreign bodies.On (b)(6)2010, the patient presented with recurrent urinary tract infections utis that seemed worse since the obtryx surgery.One uti had been associated with fever and low blood pressure and had developed while she was on macrobid.The patient also had hesitancy and incomplete emptying.She denied any leakage.Urinalysis was performed and culture was submitted.Post void residual pvr via bladder scan was 147 ml.The assessment included chronic cystitis and incomplete bladder emptying.The plan was for the patient to continue macrobid, and undergo uroflow, cystourethroscopy, and cystogram.It was noted that the sling may need to be incised if the recurrent utis could not be controlled.On (b)(6)2015, the patient presented for evaluation of urinary retention.She reported no pain and no leakage.She denied constipation, dysuria, fever, urinary frequency, hematuria, and history of diabetes.She had been self - catheterizing 6 times per day for 2 years with minimal voiding in between.The visit notes indicate the patient had undergone cystogram in august 2010 which showed incomplete emptying, but she never did any follow up.In 2012, cystometrogram showed the patient was without desire and 600 cc was drained.The patient had undergone an unspecified number of cystoscopies.The patient had intermittent utis.Genitourinary exam revealed no abnormalities.The medical record notes that possibly sling was obstructive and has slowly damaged bladder over the years and now does clean intermittent catheterization cic.The patient declined further evaluation at this time and noted she would call the physician if needed.On (b)(6)2020, the patient presented for second opinion regarding vaginal mesh erosion and recurrent utis.She has a longstanding history of a neurogenic bladder and interstitial cystitis.She underwent an ileal conduit and simple versus radical cystectomy and urethral sling removal in december 2018.However, the patient reported remnant of the mesh in her vagina.Furthermore, the patient reported the following during the visit: dyspareunia; vaginal bleeding postcoital; symptomatic with the recurrent utis including flank pain, chills, nausea, and purulent drainage from her urostomy.She had been on multiple rounds of antibiotics; improvement on her cystitis post cystectomy and conduit.Physical exam noted the ileal conduit with a healthy - appearing stoma, clear urine in the urostomy bag, and a small fragment of eroded vaginal mesh at the left apex of the vagina.The assessments were as follows: 1.Neurogenic bladder status post heal conduit december 2018, 2.Recurrent utis postoperatively, 3.Dyspareunia secondary to eroded vaginal mesh, 4.History of interstitial cystitis, 5.Neurogenic bowel.The patient was advised regarding her dyspareunia and eroded vaginal mesh that options included doing nothing versus removal if she is symptomatic.The patient wanted to have her eroded vaginal mesh removed as intercourse was painful.The patient was advised that with her history of interstitial cystitis and multiple pelvic surgeries that she may continue to have dyspareunia and/or pain post mesh removal.We also discussed that repeat surgeries can lead to recurrent scar tissue and increased pain.On (b)(6)2020, the patient presented due to erosion of implanted vaginal mesh to surrounding organ/tissue and underwent an excision of eroded vaginal mesh; transvaginal enterocele repair; looposcopy and sling removal.Her postoperative diagnoses included erosion of implanted vaginal mesh to surrounding organ/tissue and enterocele.Additionally, findings during the procedure included: 1.Eroded mesh seen along the left suburethral region extending toward the left endopelvic fascia.2.Atrophic.3.Peritoneum was seen extruding through the vagina and the suburethral mesh was adherent to the peritoneum and vagina.The peritoneum was separated off the vaginal wall.However, the mesh was adherent to the peritoneum and both the mesh and peritoneum were excised in their entirety in the suburethral region extending to the left endopelvic fascia.4.The enterocele was reduced and the peritoneum closed using 3 - 0 vicryl.5.The remnants of mesh at the left endopelvic fascia were placed on traction and excised in entirety.There is no visible mesh seen at this time.6.Her ileal conduit had a healthy stoma and there were no foreign bodies or stones within her conduit.Additional information received on september 20, 2022: office visit on (b)(6)2020: the patient came for vaginal check.She presented to rule out uti and for postop follow up.She had history of utis with back pain and just ended the course of macrobid.On (b)(6)2020, she had pap smear within normal limits.Positive for weight gain and recently started back on lupus meds.Patient felt confident that she currently has uti.No history of temps but never gets temps only back pain and chills over past 3 - 4 days reported.Positive sino - atrial; staph aureus sa since surgery last week, some left sided dyspareunia but not as bad as preoperatively.Annual health update: experiencing pain with sex: yes.Have to urinate too frequently during the day or night: yes, 5 times in an 8 - hour period.Your weight has: increased.Pelvic pain: yes - lower right quadrant; pain scale is 3/10 and 10/10 being the worst pain possible.Experiencing problems with abnormal vaginal discharge: yes.Review of systems: respiratory: she admits to asthma or wheezing.Cardiovascular: she admits to history or heart murmur and sudden heartbeat changes.Gastrointestinal: she admits to frequent diarrhea and change in bowel movements.Genitourinary: she admits to blood in urine.Gynecological: patient admits to hot flashes/night sweats.Skin/breasts: she admits to rash or itching and change in hair or nails.Musculoskeletal: she admits to joint pain, muscle pain or cramps, weakness of muscles or joints, back pain and cold extremities.Neurological: she admits to convulsions or seizures, lightheaded or dizzy, numbness or tingling sensation and tremors.Psychiatric: she admits to depression and memory loss or confusion.Endocrine: she admits to diabetes, thyroid disease, heat or cold intolerance, dry skin and excessive thirst or urination.Hematologic and lymphatic: she admits slow to heal after cuts and easily bruise or bleed.Examination: respiratory: normal breath sounds are heard bilaterally.There is no wheezing.Cardiovascular: no murmurs, rubs or gallops, with normal rate and rhythm.Skin: no significant skin changes are noted.Back: exam showed full range of motion.No spasm or tenderness was noted.Straight leg raising was negative bilaterally.No cvat.Pelvic: mild to moderate tenderness over bladder wall on vaginal exam.Vagina: vagina well healed.Moderate cystocele.Small enterocele.Small rectocele.Moderate vaginal atrophy.Impression/diagnosis: abnormal weight gain, cystocele, unspecified, dyspareunia and enterocele, vaginal, microscopic hematuria, obesity and rectocele.Spr, urinary tract infection, vaginitis, postmenopausal atrophic and vaginits, subacute/chronic.Niddm non - insulin dependent diabetes mellitus.Medications prescribed: gentamicin 40 mg/ml, take 1 ml intramuscular inject as directed.Gent 100 mg/bring to office for injection.Dispense 2.Refills 0.Diet and exercise lit given and reviewed today.Progress note dated (b)(6)2021: patient came with chief complaint of pudendal and obturator neuralgia.In march of 2020 she had the vaginal portion of the mesh removed with no change in pain.Patient presents for physical examination and to discuss treatment options going forward.Discussed removing whenever retained vaginal mesh is present as well as bilateral groin exploration for mesh excision.Physical exam: 1.General: overweight middle - aged female appears uncomfortable favoring her left side.2.Abdomen: soft, flat, no masses palpated, no hernias noted, positive tenderness associated with the left portion of her pfannenstiel scar consistent with ilioinguinal neuralgia, ileal conduit stoma healthy and functional.3.Vagina: the levator plate is moderately tender to palpation, a segment of mesh could be palpable on both inferior pubic rami, the left appears more prominent than the right, the areas are exquisitely tender, the obturator internus muscle is tender bilaterally 4.Cervix: surgically absent 5.Rectal: both sacrospinous ligament complexes are tender to palpation with a positive tinel sign.Impression: the patient has postoperative obturator and pudendal neuralgia also with evidence of left - sided ilioinguinal neuralgia.Plan: after careful consideration the patient wishes to proceed with total mesh excision.Also, we will perform a left - sided ilioinguinal/iliohypogastric neurectomy.Visit diagnosis: dyspareunia in female - primary.Postoperative obturator neuralgia.Pudendal neuralgia.Office visit on (b)(6)2021: the patient has opted to proceed with total mesh excision including the remainders of the mesh vaginally as well as a bilateral groin exploration for mesh excision.She also wants to proceed with a left - sided ilioinguinal/iliohypogastric neurectomy.Procedures scheduled on (b)(6)2021.Additionally, the patient was reported to be allergic to cephalosporins, fentanyl, lamictal, sulfa, vancomycin.Mesh excision on (b)(6) 2021: preoperatively, the patient was diagnosed with pudendal neuralgia, obturator neuralgia, left - sided ilioinguinal neuralgia, and dyspareunia.On palpation, appeared to be a significant piece of mesh palpable on the left anterior fornix of the vagina, which corresponded to her preoperative examination of an area of exquisite tenderness.On the right findings were much more subtle, possibly just consistent with scar tissue.Piece of mesh on the right, left and groin were identified and dissected and saved for pathology.The patient was awakened in the operating room, brought to recovery room awake, alert, in apparent stable condition.Postoperatively, a segment of mesh was retrieved from the left anterior lateral vaginal compartment with no mesh retrieved on the right, large piece of mesh retrieved from both groin dissections, it would appear all the mesh was removed.Final pathological diagnosis: 1.Left ilioinguinal nerve: fibroadipose tissue with large nerve fibers, and adjacent skeletal muscle.2.Bilateral groin and vaginal mesh: fibromuscular and adipose tissue with chronic inflammation, multinucleated giant cell reaction, and foreign body consistent with mesh.Fragment of squamous mucosa with hemorrhage.On (b)(6)2021, patient came into the emergency room today with complaint of right flank pain and a right urostomy was not draining.She also had some low - grade fever.No chest pain shortness of breath.She was also noticed to be tachycardic and has low grade fever.On exam she is alert awake and oriented not in distress.Lungs clear.Abdomen is soft.Lleal conduit in place.Bilateral nephrostomy tube is now draining.Both lower extremity no edema.Plan patient will be kept under observation for sirs - systemic inflammatory response syndrome, she will be on iv hydration and supportive care.Case was discussed by er physician with infectious disease physician who recommended to hold off antibiotics unless she continues to spike fever or clear evidence of infection.Initial presentation for malfunctioning nephrostomy tube which spontaneously started working.Ct scan does not show any obvious blockage.Urology was consulted by er physician.Supportive care for now.Patient appears to have subconjunctival hemorrhage.Will use scds for dvt prophylaxis.Discharge diagnosis: principal problem: obstructed nephrostomy tube cms/hcc.Active problems: hypertensive heart disease without heart failure.Sle systemic lupus erythematosus related syndrome cms/hcc.Recurrent uti.Wound of left groin.Retinal hemorrhage of both eyes.Diabetes mellitus type 2 in obese cms/hcc.Hypothyroid.Resolved problems: tachycardia.Additional information received on october 13, 2022: on (b)(6)2017, patient came for urological evaluation.She stated that frequency symptoms had not changed.She always had pain or burning with urination.She had a history of frequent uti.Urgency symptoms had not changed.She had been treated with oral medications.Medications tried for bladder symptoms are elmiron instillations.She was diagnosed with interstitial cystitis by cysto and had to undergo weekly elmiron instillations.The most bothersome urinary compliant is burning and problems going.On may 13, 2016, she developed uti.Her urine looks clear today.She had been having a lot of bladder pain and lower abdominal pain.Catheter also hurt.Last year, patient saw a physician and ordered urodynamics which demonstrated a large capacity bladder with no sensation or urge at 750ccs but with staccato like d.O., good compliance.Patient also had a history of cyclophosphamide use.She had a recent uti and pyelonephritis status post treatment with cipro three weeks ago and iv levaquin for two weeks total.Issues with diarrhea.Her post void residual today is 283.She did not get an improvement with elavil, and she is getting elmiron per bladder to avoid interactions with her other medications.She had been stable for a year on this regimen.She said she never emptied her bladder and was willing to cic, clean intermittent catheterization.However, on september 16, 2013, she had been unable to cic and it was giving her flank pain.Her follow up renal ultrasound on (b)(6)2013 demonstrated resolution of her previous right hydronephrosis.She was only on catheter twice daily, had a uti currently and still had left flank pain with a full bladder.On (b)(6)2014, her renal ultrasound is negative for hydronephrosis but demonstrated a right renal stone x1.Had been doing cics per day and sometimes got large amounts of urine out and had less back/side pain and less fullness in her right pelvis.She noticed that her pain improved with the increase in the number of cics.Renal ultrasound performed again on (b)(6)2014 and still no hydro visible.On (b)(6)2016, her cysto demonstrated severe stenosis status post dilation.Exam revealed moderate atrophy peri - urethrally, a grade 1 cystocele.On (b)(6)2017, estrace discontinued due to blood clot risk.Genito - urinary past medical history: urethral stricture, unspecified (urethral stricture) - (b)(6)2016 dysuria - (b)(6)/2016 & (b)(6)2014 urinary retention - (b)(6)2014 incomplete bladder emptying - 2013.Additional information received on november 8 and 15, 2022 on (b)(6)2020, the patient came for urological evaluation for urinary symptoms.It was reported that on (b)(6)2017, pelvic pain and pain with intercourse is improved with physiotherapy, but still having pain when cathing, and incontinence.She was status post perc test on (b)(6)2017.She had the best response on the left and was able to urinate on her own.Patient did clean intermittent catheterization with each side, and it helped with her bowel movement.She wanted to proceed with the permanent procedure.Patient stated the hyoscyamine was no longer helping her bladder pain.On (b)(6)2017, status post interstim placement and it helped her symptoms.Continued to cath 4 to 8 times daily, her pain is well - controlled, but still required pain meds at night.Her incision was well - healed.On (b)(6)2017, she was doing well post interstim.Her clean intermittent catheterization was down to once or twice per day.She got the highest residuals at night.Her pain was improved but not gone away.On (b)(6)2018, her sample urine is very dark yellow.Continued to have left flank pain that was improved with cathing.Urinary diversion versus botox was discussed as the patient was very frustrated.On (b)(6)2019, the patient was status post urinary diversion.Complicated post operation by sepsis.Had treated for presumed utis since.These have been relatively asymptomatic and related to colonization.Some left renal colic.Ct stone did not demonstrate anything that should be causing pain.No hydro/hernias.During a visit on (b)(6)2013, the patient was complaining of blood in urine and microhematuria was found on urinalysis after the treatment for uti.She was then status post negative microhematuria workup.On (b)(6)2020, patient came for a follow up through synchronous audio and video technology.She presented with complicated uti.Ciprofloxacin medicine was ordered for 14 more days, and it was likely that the patient was going to have a prolonged antibiotic therapy.There was also a possible clostridium difficile complication.Patient was having fevers likely due to reclast, if worsened she was advised to go to the er.It was also stated that her urine was clearer, had ran temperature of 102 all night.She just had a procedure done a day before.In history, it was stated that patient has been on multiple antibiotics for recurrent urinary tract infection.She had enterococcus faecalis, klebsiella oxytoca isolated in her urine cultures.Patient reported that she felt somewhat better after taking antibiotics but then had pus coming out of urostomy bag a few days later.During a follow up on (b)(6)2021, it was stated that the patient had finished iv daptomycin and peripherally inserted central catheter had been removed.Additionally, the patient answered a questionnaire stating that she was entitled to medicare based on disability.New or worsening symptoms of fatigue.Additional information received on january 24, 2023: doctor's note on (b)(6)2020 ct scan of abdomen and pelvic with contrast shows finding as below: postsurgical change of prior cystectomy and ileal conduit, as above.No bowel or urinary tract obstruction.Small low - density lesions in the kidneys noted above that are stable compared to prior study and may reflect cysts but are too small for definitive characterization.New large area of indistinct hypodensity in the right kidney at the lower pole that would suggest infectious or inflammatory disease.Neoplasm less likely.Clinical and urinalysis correlation is recommended.Follow - up to assess for resolution.Date of admission: (b)(6)2020.Date of discharge: (b)(6)2020.Discharge diagnosis: principal problem - pyelonephritis.Active problem - systemic lupus erythematosus related syndrome), nausea, hypertensive heart disease without heart failure, other specified hypothyroidsm, recurrent uti, diabetes mellitus type 2 in obese, herpes labialis.Reason for hospitalization: pyelonephritis recently removed bladder mesh in (b)(6)2020, who came into the emergency room with complaint of fever for the last 2 to 3 days as well as right - sided flank pain.Patient stated she has had recurrent episodes of urinary tract infection as well as kidney infection.Had been on antibiotics numerous times due to recurring utis for the past year.Mesh was encroaching into her intestines, for which the mesh was removed in march but with no follow up appointment since then.Physical exam: abdominal - right cva tenderness.On (b)(6)2021, patient presented to the emergency department for evaluation of draining surgical wound to her left groin.The patient stated she had mesh removed from previous bladder sling two weeks ago.The wound had been draining for the past 12 days.She was also complaining of a subjective fever, chills, nausea, and right sided back pain.Consultation note stated patient had small dehiscence of her left groin wound.She recently had abdominal mesh removal for dyspareunia - thought to be due to predental neuralgia from the mesh.Patient was in the er due to concern for wound infection and concern for uti.She reported she as very tired and sleepy.Reports drenching sweats and chills at home.Discharge diagnosis on (b)(6)2021 active problem: vaginal discharge.Reason for hospitalization: acute uti systemic inflammatory response syndrome complicated uti hpi: she reported noting drainage from her groin wounds for about the last 12 days and the wounds were tender.Right groin wound was healing well but there is an open area in the anterior portion of her left groin wound.She described her right flank pain as deep dull ache.Pain had improved after recently receiving antibiotics.Patient's fever curve and leukocytosis improved during her hospitalization.Antibiotics were eventually de - escalated to iv invanz.Peripherally inserted central catheter line was placed in march 31 after blood cultures remained negative.Patient was stable for discharge but was delayed until april 2 due to outpatient antibiotic arrangements.She was on iv invanz until april 9.- virtual visit on april 4, 2022 surgical pathology report from simple cystectomy shows benign bladder with focally keratinizing squamous cell metaplasia, pathy hyperplasia and minimal mural fibrosis and disorganization on 12/21/2018.Immediately after mesh removal she got septic.In 2020, she started getting infections.She thinks she was getting infections every month that have put her in the hospitals, her symptoms are always fever, chills, pus in urine, tachycardia, smelly urine, weakness and fatigue.Impression on ct abdomen and pelvis with contrast on (b)(6)2022, patient had mild bilateral pelvicaliectasis, left greater than right, with minimal prominence of the bilateral ureters extending to the conduit, nonspecific and likely physiologic.Office note stated patient had stenosis of ileal conduit stoma, recurrent uti and hydronephrosis.It lead to potential revision surgery that may or may not impact infection.On (b)(6)2022, patient reported that when she had the mesh removed, her wound got her groin infected and had to pack it for a while.

Manufacturer Narrative

Blocks b5, b6 and h6 patient codes and impact codes have been updated based on the additional information received on january 24, 2023.Block b3: the exact event onset date is unknown; however, it was reported that the patient had a first office visit on (b)(6)2010, due to symptoms.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6)hospital.Explant surgeons are: *dr.(b)(6).*dr.(b)(6).Block h6: imdrf patient codes e2006, e1309, e2114, e1405, e232401, e2330, e1906, e1310, e2015, e0123, e2101, e1715, e1302, e1401, e2326, e2401, e2337, e1301 and e172001 capture the reportable events of erosion, urinary retention, perforation, dyspareunia, fecal incontinence, pain, unspecified infection, urinary tract injury, unspecified tissue injury, nerve damage and adhesion, hematuria, abnormal vaginal discharge, inflammation, and wound of left groin, urethral stricture and severe stenosis, dysuria and abscess.Imdrf impact codes f1901, f1903, f1202 and f08 capture the reportable events of surgical intervention, all the mesh was removed, disability and patient was hospitalized due to acute and complicated uti and systemic inflammatory response syndrome.Correction: block d6b: explant date has been corrected.(it appeared all the mesh was removed on (b)(6)2021).

Manufacturer Narrative

Blocks b5, b7 and h6: patient codes have been updated based on the additional information received on july 25, 2023.Block b3: the exact event onset date is unknown; however, it was reported that the patient had a first office visit on (b)(6) 2010, due to symptoms.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Explant surgeons are: dr.(b)(6).Block h6: imdrf patient codes e2006, e1309, e2114, e1405, e232401, e2330, e1906, e1310, e2015, e0123, e2101, e1715, e1302, e1401, e2326, e2401, e2337, e1301, e172001 and e1705 capture the reportable events of erosion, urinary retention, perforation, dyspareunia, fecal incontinence, pain, unspecified infection, urinary tract injury, unspecified tissue injury, nerve damage and adhesion, hematuria, abnormal vaginal discharge, inflammation, and wound of left groin, urethral stricture and severe stenosis, dysuria and abscess, and vaginal burning.Imdrf impact codes f1901, f1903, f1202 and f08 capture the reportable events of surgical intervention, all the mesh was removed, disability and patient were hospitalized due to acute and complicated uti and systemic inflammatory response syndrome.Correction: block e3: occupation has been corrected.

Event Description

It was reported to boston scientific corporation that an obtryx halo system device was implanted into the patient during a procedure performed on (b)(6) 2010.As reported by the patient's attorney, the patient experienced an unspecified injury.**additional information received on january 14, 2022: on (b)(6) 2010, a hysterectomy was performed prior to the sling placement.The operative report for the obtryx implant notes that on the patient's left side, there was some perforation of the skin lateral to the vaginal incision on the left which was recognized, and the needle was placed beneath this.Cystoscopy was performed and the operative report states the patient had some methylene blue which made visualization a bit difficult.There was some redundant vaginal mucosa along the left trigone.The remainder of the bladder was free of any lesions, stones, or foreign bodies.On (b)(6) 2010, the patient presented with recurrent urinary tract infections utis that seemed worse since the obtryx surgery.One uti had been associated with fever and low blood pressure and had developed while she was on macrobid.The patient also had hesitancy and incomplete emptying.She denied any leakage.Urinalysis was performed and culture was submitted.Post void residual pvr via bladder scan was 147 ml.The assessment included chronic cystitis and incomplete bladder emptying.The plan was for the patient to continue macrobid, and undergo uroflow, cystourethroscopy, and cystogram.It was noted that the sling may need to be incised if the recurrent utis could not be controlled.On (b)(6) 2015, the patient presented for evaluation of urinary retention.She reported no pain and no leakage.She denied constipation, dysuria, fever, urinary frequency, hematuria, and history of diabetes.She had been self - catheterizing 6 times per day for 2 years with minimal voiding in between.The visit notes indicate the patient had undergone cystogram in (b)(6) 2010 which showed incomplete emptying, but she never did any follow up.In 2012, cystometrogram showed the patient was without desire and 600 cc was drained.The patient had undergone an unspecified number of cystoscopies.The patient had intermittent utis.Genitourinary exam revealed no abnormalities.The medical record notes that possibly sling was obstructive and has slowly damaged bladder over the years and now does clean intermittent catheterization cic.The patient declined further evaluation at this time and noted she would call the physician if needed.On (b)(6) 2020, the patient presented for second opinion regarding vaginal mesh erosion and recurrent utis.She has a longstanding history of a neurogenic bladder and interstitial cystitis.She underwent an ileal conduit and simple versus radical cystectomy and urethral sling removal in (b)(6) 2018.However, the patient reported remnant of the mesh in her vagina.Furthermore, the patient reported the following during the visit: dyspareunia; vaginal bleeding postcoital; symptomatic with the recurrent utis including flank pain, chills, nausea, and purulent drainage from her urostomy.She had been on multiple rounds of antibiotics; improvement on her cystitis post cystectomy and conduit.Physical exam noted the ileal conduit with a healthy - appearing stoma, clear urine in the urostomy bag, and a small fragment of eroded vaginal mesh at the left apex of the vagina.The assessments were as follows: 1.Neurogenic bladder status post heal conduit (b)(6) 2018.2.Recurrent utis postoperatively.3.Dyspareunia secondary to eroded vaginal mesh.4.History of interstitial cystitis.5.Neurogenic bowel.The patient was advised regarding her dyspareunia and eroded vaginal mesh that options included doing nothing versus removal if she is symptomatic.The patient wanted to have her eroded vaginal mesh removed as intercourse was painful.The patient was advised that with her history of interstitial cystitis and multiple pelvic surgeries that she may continue to have dyspareunia and/or pain post mesh removal.We also discussed that repeat surgeries can lead to recurrent scar tissue and increased pain.On (b)(6) 2020, the patient presented due to erosion of implanted vaginal mesh to surrounding organ/tissue and underwent an excision of eroded vaginal mesh; transvaginal enterocele repair; looposcopy and sling removal.Her postoperative diagnoses included erosion of implanted vaginal mesh to surrounding organ/tissue and enterocele.Additionally, findings during the procedure included: 1.Eroded mesh seen along the left suburethral region extending toward the left endopelvic fascia.2.Atrophic.3.Peritoneum was seen extruding through the vagina and the suburethral mesh was adherent to the peritoneum and vagina.The peritoneum was separated off the vaginal wall.However, the mesh was adherent to the peritoneum and both the mesh and peritoneum were excised in their entirety in the suburethral region extending to the left endopelvic fascia.4.The enterocele was reduced and the peritoneum closed using 3 - 0 vicryl.5.The remnants of mesh at the left endopelvic fascia were placed on traction and excised in entirety.There is no visible mesh seen at this time.6.Her ileal conduit had a healthy stoma and there were no foreign bodies or stones within her conduit.Additional information received on september 20, 2022: office visit on may 12, 2020: the patient came for vaginal check.She presented to rule out uti and for postop follow up.She had history of utis with back pain and just ended the course of macrobid.On (b)(6) 2020, she had pap smear within normal limits.Positive for weight gain and recently started back on lupus meds.Patient felt confident that she currently has uti.No history of temps but never gets temps only back pain and chills over past 3 - 4 days reported.Positive sino - atrial; staph aureus sa since surgery last week, some left sided dyspareunia but not as bad as preoperatively.Annual health update: experiencing pain with sex: yes.Have to urinate too frequently during the day or night: yes, 5 times in an 8 - hour period.Your weight has: increased.Pelvic pain: yes - lower right quadrant; pain scale is 3/10 and 10/10 being the worst pain possible.Experiencing problems with abnormal vaginal discharge: yes.Review of systems: respiratory: she admits to asthma or wheezing.Cardiovascular: she admits to history or heart murmur and sudden heartbeat changes.Gastrointestinal: she admits to frequent diarrhea and change in bowel movements.Genitourinary: she admits to blood in urine.Gynecological: patient admits to hot flashes/night sweats.Skin/breasts: she admits to rash or itching and change in hair or nails.Musculoskeletal: she admits to joint pain, muscle pain or cramps, weakness of muscles or joints, back pain and cold extremities.Neurological: she admits to convulsions or seizures, lightheaded or dizzy, numbness or tingling sensation and tremors.Psychiatric: she admits to depression and memory loss or confusion.Endocrine: she admits to diabetes, thyroid disease, heat or cold intolerance, dry skin and excessive thirst or urination.Hematologic and lymphatic: she admits slow to heal after cuts and easily bruise or bleed.Examination: respiratory: normal breath sounds are heard bilaterally.There is no wheezing.Cardiovascular: no murmurs, rubs or gallops, with normal rate and rhythm.Skin: no significant skin changes are noted.Back: exam showed full range of motion.No spasm or tenderness was noted.Straight leg raising was negative bilaterally.No cvat.Pelvic: mild to moderate tenderness over bladder wall on vaginal exam.Vagina: vagina well healed.Moderate cystocele, small enterocele, small rectocele, moderate vaginal atrophy.Impression/diagnosis: abnormal weight gain, cystocele, unspecified, dyspareunia and enterocele, vaginal, microscopic hematuria, obesity and rectocele.Spr, urinary tract infection, vaginitis, postmenopausal atrophic and vaginits, subacute/chronic.Niddm non - insulin dependent diabetes mellitus.Medications prescribed: gentamicin 40 mg/ml, take 1 ml intramuscular inject as directed.Gent 100 mg/bring to office for injection.Dispense 2.Refills 0.Diet and exercise lit given and reviewed today.Progress note dated (b)(6) 2021: patient came with chief complaint of pudendal and obturator neuralgia.In (b)(6) 2020 she had the vaginal portion of the mesh removed with no change in pain.Patient presents for physical examination and to discuss treatment options going forward.Discussed removing whenever retained vaginal mesh is present as well as bilateral groin exploration for mesh excision.Physical exam: 1.General: overweight middle - aged female appears uncomfortable favoring her left side.2.Abdomen: soft, flat, no masses palpated, no hernias noted, positive tenderness associated with the left portion of her pfannenstiel scar consistent with ilioinguinal neuralgia, ileal conduit stoma healthy and functional.3.Vagina: the levator plate is moderately tender to palpation, a segment of mesh could be palpable on both inferior pubic rami, the left appears more prominent than the right, the areas are exquisitely tender, the obturator internus muscle is tender bilaterally 4.Cervix: surgically absent.5.Rectal: both sacrospinous ligament complexes are tender to palpation with a positive tinel sign.Impression: the patient has postoperative obturator and pudendal neuralgia also with evidence of left - sided ilioinguinal neuralgia.Plan: after careful consideration the patient wishes to proceed with total mesh excision.Also, we will perform a left - sided ilioinguinal/iliohypogastric neurectomy.Visit diagnosis: dyspareunia in female - primary.Postoperative obturator neuralgia.Pudendal neuralgia.Office visit on (b)(6) 2021: the patient has opted to proceed with total mesh excision including the remainders of the mesh vaginally as well as a bilateral groin exploration for mesh excision.She also wants to proceed with a left-sided ilioinguinal/iliohypogastric neurectomy.Procedures scheduled on (b)(6) 2021.Additionally, the patient was reported to be allergic to cephalosporins, fentanyl, lamictal, sulfa, vancomycin.Mesh excision on (b)(6) 2021: preoperatively, the patient was diagnosed with pudendal neuralgia, obturator neuralgia, left-sided ilioinguinal neuralgia, and dyspareunia.On palpation, appeared to be a significant piece of mesh palpable on the left anterior fornix of the vagina, which corresponded to her preoperative examination of an area of exquisite tenderness.On the right findings were much more subtle, possibly just consistent with scar tissue.Piece of mesh on the right, left and groin were identified and dissected and saved for pathology.The patient was awakened in the operating room, brought to recovery room awake, alert, in apparent stable condition.Postoperatively, a segment of mesh was retrieved from the left anterior lateral vaginal compartment with no mesh retrieved on the right, large piece of mesh retrieved from both groin dissections, it would appear all the mesh was removed.Final pathological diagnosis: 1.Left ilioinguinal nerve: fibroadipose tissue with large nerve fibers, and adjacent skeletal muscle.2.Bilateral groin and vaginal mesh: fibromuscular and adipose tissue with chronic inflammation, multinucleated giant cell reaction, and foreign body consistent with mesh.Fragment of squamous mucosa with hemorrhage.On (b)(6) 2021, patient came into the emergency room today with complaint of right flank pain and a right urostomy was not draining.She also had some low - grade fever.No chest pain shortness of breath.She was also noticed to be tachycardic and has low grade fever.On exam she is alert awake and oriented not in distress.Lungs clear.Abdomen is soft.Lleal conduit in place.Bilateral nephrostomy tube is now draining.Both lower extremity no edema.Plan patient will be kept under observation for sirs - systemic inflammatory response syndrome, she will be on iv hydration and supportive care.Case was discussed by er physician with infectious disease physician who recommended to hold off antibiotics unless she continues to spike fever or clear evidence of infection.Initial presentation for malfunctioning nephrostomy tube which spontaneously started working.Ct scan does not show any obvious blockage.Urology was consulted by er physician.Supportive care for now.Patient appears to have subconjunctival hemorrhage.Will use scds for dvt prophylaxis.Discharge diagnosis principal problem: obstructed nephrostomy tube cms/hcc.Active problems: hypertensive heart disease without heart failure.Sle systemic lupus erythematosus related syndrome cms/hcc.Recurrent uti.Wound of left groin.Retinal hemorrhage of both eyes.Diabetes mellitus type 2 in obese cms/hcc.Hypothyroid.Resolved problems: tachycardia.Additional information received on october 13, 2022--- on january 13, 2017, patient came for urological evaluation.She stated that frequency symptoms had not changed.She always had pain or burning with urination.She had a history of frequent uti.Urgency symptoms had not changed.She had been treated with oral medications.Medications tried for bladder symptoms are elmiron instillations.She was diagnosed with interstitial cystitis by cysto and had to undergo weekly elmiron instillations.The most bothersome urinary compliant is burning and problems going.On (b)(6) 2016, she developed uti.Her urine looks clear today.She had been having a lot of bladder pain and lower abdominal pain.Catheter also hurt.Last year, patient saw a physician and ordered urodynamics which demonstrated a large capacity bladder with no sensation or urge at 750ccs but with staccato like d.O., good compliance.Patient also had a history of cyclophosphamide use.She had a recent uti and pyelonephritis status post treatment with cipro three weeks ago and iv levaquin for two weeks total.Issues with diarrhea.Her post void residual today is 283.She did not get an improvement with elavil, and she is getting elmiron per bladder to avoid interactions with her other medications.She had been stable for a year on this regimen.She said she never emptied her bladder and was willing to cic, clean intermittent catheterization.However, on (b)(6) 2013, she had been unable to cic and it was giving her flank pain.Her follow up renal ultrasound on (b(6) 2013 demonstrated resolution of her previous right hydronephrosis.She was only on catheter twice daily, had a uti currently and still had left flank pain with a full bladder.On (b)(6) 2014, her renal ultrasound is negative for hydronephrosis but demonstrated a right renal stone x1.Had been doing cics per day and sometimes got large amounts of urine out and had less back/side pain and less fullness in her right pelvis.She noticed that her pain improved with the increase in the number of cics.Renal ultrasound performed again on (b)(6) 2014 and still no hydro visible.On (b)(6) 2016, her cysto demonstrated severe stenosis status post dilation.Exam revealed moderate atrophy peri - urethrally, a grade 1 cystocele.On (b)(6) 2017, estrace discontinued due to blood clot risk.Genito - urinary past medical history: urethral stricture, unspecified (urethral stricture) - (b)(6) 2016, dysuria - (b)(6) 2016 & (b)(6) 2014, urinary retention - (b)(6) 2014, incomplete bladder emptying - 2013.Additional information received on november 8 and 15, 2022: on (b)(6) 2020, the patient came for urological evaluation for urinary symptoms.It was reported that on (b)(6) 2017, pelvic pain and pain with intercourse is improved with physiotherapy, but still having pain when cathing, and incontinence.She was status post perc test on (b)(6) 2017.She had the best response on the left and was able to urinate on her own.Patient did clean intermittent catheterization with each side, and it helped with her bowel movement.She wanted to proceed with the permanent procedure.Patient stated the hyoscyamine was no longer helping her bladder pain.On (b)(6) 2017, status post interstim placement and it helped her symptoms.Continued to cath 4 to 8 times daily, her pain is well - controlled, but still required pain meds at night.Her incision was well - healed.On (b)(6) 2017, she was doing well post interstim.Her clean intermittent catheterization was down to once or twice per day.She got the highest residuals at night.Her pain was improved but not gone away.On (b)(6) 2018, her sample urine is very dark yellow.Continued to have left flank pain that was improved with cathing.Urinary diversion versus botox was discussed as the patient was very frustrated.On (b)(6) 2019, the patient was status post urinary diversion.Complicated post operation by sepsis.Had treated for presumed utis since.These have been relatively asymptomatic and related to colonization.Some left renal colic.Ct stone did not demonstrate anything that should be causing pain.No hydro/hernias.During a visit on (b)(6) 2013, the patient was complaining of blood in urine and microhematuria was found on urinalysis after the treatment for uti.She was then status post negative microhematuria workup.On (b)(6) 2020, patient came for a follow up through synchronous audio and video technology.She presented with complicated uti.Ciprofloxacin medicine was ordered for 14 more days, and it was likely that the patient was going to have a prolonged antibiotic therapy.There was also a possible clostridium difficile complication.Patient was having fevers likely due to reclast, if worsened she was advised to go to the er.It was also stated that her urine was clearer, had ran temperature of 102 all night.She just had a procedure done a day before.In history, it was stated that patient has been on multiple antibiotics for recurrent urinary tract infection.She had enterococcus faecalis, klebsiella oxytoca isolated in her urine cultures.Patient reported that she felt somewhat better after taking antibiotics but then had pus coming out of urostomy bag a few days later.During a follow up on (b)(6) 2021, it was stated that the patient had finished iv daptomycin and peripherally inserted central catheter had been removed.Additionally, the patient answered a questionnaire stating that she was entitled to medicare based on disability.New or worsening symptoms of fatigue.Additional information received on january 24, 2023: doctor's note on (b)(6) 2020: ct scan of abdomen and pelvic with contrast shows finding as below: postsurgical change of prior cystectomy and ileal conduit, as above.No bowel or urinary tract obstruction.Small low-density lesions in the kidneys noted above that are stable compared to prior study and may reflect cysts but are too small for definitive characterization.New large area of indistinct hypodensity in the right kidney at the lower pole that would suggest infectious or inflammatory disease.Neoplasm less likely.Clinical and urinalysis correlation is recommended.Follow-up to assess for resolution.Date of admission: (b)(6) 2020.Date of discharge: (b)(6) 2020.Discharge diagnosis: principal problem - pyelonephritis.Active problem - systemic lupus erythematosus related syndrome), nausea, hypertensive heart disease without heart failure, other specified hypothyroidsm, recurrent uti, diabetes mellitus type 2 in obese, herpes labialis.Reason for hospitalization: pyelonephritis.Recently removed bladder mesh in (b)(6) 2020, who came into the emergency room with complaint of fever for the last 2 to 3 days as well as right-sided flank pain.Patient stated she has had recurrent episodes of urinary tract infection as well as kidney infection.Had been on antibiotics numerous times due to recurring utis for the past year.Mesh was encroaching into her intestines, for which the mesh was removed in march but with no follow up appointment since then.Physical exam: abdominal - right cva tenderness.On (b)(6) 2021, patient presented to the emergency department for evaluation of draining surgical wound to her left groin.The patient stated she had mesh removed from previous bladder sling two weeks ago.The wound had been draining for the past 12 days.She was also complaining of a subjective fever, chills, nausea, and right sided back pain.Consultation note stated patient had small dehiscence of her left groin wound.She recently had abdominal mesh removal for dyspareunia - thought to be due to predental neuralgia from the mesh.Patient was in the er due to concern for wound infection and concern for uti.She reported she as very tired and sleepy.Reports drenching sweats and chills at home.Discharge diagnosis on (b)(6) 2021.Active problem: vaginal discharge.Reason for hospitalization: acute uti, systemic inflammatory response syndrome, complicated uti.Hpi: she reported noting drainage from her groin wounds for about the last 12 days and the wounds were tender.Right groin wound was healing well but there is an open area in the anterior portion of her left groin wound.She described her right flank pain as deep dull ache.Pain had improved after recently receiving antibiotics.Patient's fever curve and leukocytosis improved during her hospitalization.Antibiotics were eventually de-escalated to iv invanz.Peripherally inserted central catheter line was placed in (b)(6) after blood cultures remained negative.Patient was stable for discharge but was delayed until (b)(6) due to outpatient antibiotic arrangements.She was on iv invanz until (b)(6).Virtual visit on (b)(6) 2022: surgical pathology report from simple cystectomy shows benign bladder with focally keratinizing squamous cell metaplasia, pathy hyperplasia and minimal mural fibrosis and disorganization on (b)(6) 2018.Immediately after mesh removal she got septic.In 2020, she started getting infections.She thinks she was getting infections every month that have put her in the hospitals, her symptoms are always fever, chills, pus in urine, tachycardia, smelly urine, weakness and fatigue.Impression on ct abdomen and pelvis with contrast on (b)(6) 2022, patient had mild bilateral pelvicaliectasis, left greater than right, with minimal prominence of the bilateral ureters extending to the conduit, nonspecific and likely physiologic.Office note stated patient had stenosis of ileal conduit stoma, recurrent uti and hydronephrosis.It lead to potential revision surgery that may or may not impact infection.On (b)(6) 2022, patient reported that when she had the mesh removed, her wound got her groin infected and had to pack it for a while.Additional information received on july 25, 2023: in a progress note on (b)(6) 2021, it was stated that the patient continued with her prior pain complaints but also noted reduced clitoral sensitivity.Orgasm was difficult to achieve and sometimes could be painful.She noted sitting with pain in the rectum and coccyx; constipation which was laxative dependent.She could have dyschezia.She also noted vaginal burning and perineal pain.

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Brand Name

OBTRYX SYSTEM

Type of Device

MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Manufacturer (Section D)

BOSTON SCIENTIFIC CORPORATION

300 boston scientific way

marlborough MA 01752

Manufacturer (Section G)

FREUDENBERG MEDICAL MIS INC

2301 centennial boulevard

jeffersonville IN 47130

Manufacturer Contact

carole morley

300 boston scientific way

marlborough, MA 01752

5086834015

MDR Report Key

11603410

MDR Text Key

243403880

Report Number

3005099803-2021-01341

Device Sequence Number

Product Code

OTN

UDI-Device Identifier

08714729718994

UDI-Public

08714729718994

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

K040787

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Consumer,Company Representative

Reporter Occupation

Non-Healthcare Professional

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

04/01/2021

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Expiration Date

01/31/2013

Device Model Number

M0068505001

Device Catalogue Number

850-500

Device Lot Number

1ML0011808

Was Device Available for Evaluation?

Date Manufacturer Received

07/25/2023

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Date Device Manufactured

03/01/2010

Is the Device Single Use?

Yes

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Other; Required Intervention;

Patient Age

28 YR

Patient Sex

Female

Patient Weight

95 KG

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

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