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

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

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Model Number M0068505110

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Bacterial Infection (1735); Fatigue (1849); Micturition Urgency (1871); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Muscle Weakness (1967); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Vomiting (2144); Urinary Frequency (2275); Anxiety (2328); Injury (2348); Depression (2361); Numbness (2415); Diaphoresis (2452); Prolapse (2475); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Constipation (3274); Paresthesia (4421); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Musculoskeletal problem (4535); Urinary Incontinence (4572); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 04/16/2018

Event Type Injury

Manufacturer Narrative

Date of event was approximated to (b)(6) 2018, implant date, as no event date was reported.The reported lot number (21452431) does not provide a match in the system search; therefore, the device manufacture and expiration dates cannot be determined.(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

This manufacturer report pertains to the second of two devices used during the same procedure.It was reported to boston scientific corporation that an upsylon y-mesh device and an obtryx ii system - halo devices were implanted into the patient during a procedure performed on (b)(6) 2018.As reported by the patient's attorney, the patient has experienced an unspecified injury.Boston scientific has been unable to obtain additional information regarding the event to date.

Manufacturer Narrative

Additional information: blocks d4, e1 (below) and h4 correction: a3 - no patient gender originally reported block b3 date of event: date of event was approximated to (b)(6) 2018, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6) (b)(6) block h6: patient code e2401 captures the reportable event of unknown injury.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.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

This manufacturer report pertains to the second of two devices used during the same procedure.It was reported to boston scientific corporation that an upsylon y-mesh and obtryx ii system - halo devices were implanted into the patient during a procedure performed on (b)(6) 2018.As reported by the patient's attorney, the patient has experienced an unspecified injury.

Event Description

Manufacturer Narrative

Correction: blocks b5 and h6: patient codes, impact codes and device codes.Block b3 date of event: date of event was approximated to (b)(6) 2018, date symptoms initially reported during a clinic visit, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The mesh removal surgeon is: (b)(6).Block h6: patient codes e2330, e1002, e2333, e1405, e0130, e0116, e1605, e1020, e0126, e2101, e1715, e1901 and e0402 capture the reportable event of pelvic and groin pain, abdominal pain, pelvic organ prolapse, dyspareunia, insomnia, migraine, muscle spasms, nausea, neuropathy, adhesions, scar tissue, vaginosis and hypersensitivity.Impact codes f19, f2303 and f1202 capture the reportable event of mesh removal, medications required to control pain and not being able to work.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.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6), 2018, date symptoms initially reported during a clinic visit, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The mesh removal surgeon is: (b)(6).Block h6: patient codes e2330, e1002, e2333, e1405, e0130, e0116, e1605, e1020, e0126, e2101, e1715 capture the reportable event of pelvic and groin pain, abdominal pain, pelvic organ prolapse, dyspareunia, insomnia, migraine, muscle spasms, nausea, neuropathy, adhesions, scar tissue.Impact codes f19 and f2303 capture the reportable event of surgical intervention (mesh removal) and medications required to control pain.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.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

Note: this manufacturer report pertains to the second of two devices used during the same procedure.It was reported to boston scientific corporation that an upsylon y-mesh and an obtryx ii system - halo were implanted into the patient during a procedure performed on (b)(6), 2018.As reported by the patient's attorney, the patient has experienced an unspecified injury.-additional information received on january 14, 2022- it was reported that the patient has a history of pelvic organ prolapse, urge incontinence, as well as uterine leiomyoma.Pre-op diagnosis includes stress urinary incontinence.On (b)(6), 2018, a robotic-assisted hysterectomy was performed, followed by robotic-assisted laparoscopic sacrocolpopexy and synthetic mid-urethral sling obturator and cystourethroscopy.The procedure was tolerated well without complications.On (b)(6), 2018, patient reports experiencing stress incontinence (when she bends over and bladder is full, but better than before surgery), urge incontinence (but improved from prior to surgery) and urgency.She also reports some tail bone pain which only started two weeks ago.She reports she cannot sit for prolonged periods of time.She does report some lower abdominal pain intermittently and suprapubic pressure, but this is all improving.She also had some upper abdominal cramps which is essentially resolved.Exam revealed grade 2 rectocele, normal vaginal mucosa, and no mesh erosions.Urinalysis was normal and postvoid residual (pvr) was 31 ml.The impression included rectocele, minimal stress incontinence for which she was having pelvic floor physical therapy (pfpt), urge incontinence for which the patient was to resume myrbetriq, and vaginosis for which the patient was to start metrogel vaginally.On (b)(6), 2018, patient presented for perimenopausal/menopausal symptoms post-hysterectomy.She also reported pelvic pain characterized as crampy, intermittent, severe, radiating to the back, aggravated by physical activity.Note: pain is improving, she has regained her multiple orgasm status and is happy about this.Exam was consistent with pelvic floor/levator tenderness and tight muscles.The patient was taught pelvic floor relaxation techniques.On (b)(6), 2020, patient presents with complaints of mesh complication, lower abdominal pain, pelvic and groin pain and lower back pain.Patient states her problems started after the surgery she had which included an lavh, sc and sling.Seven weeks post-op she had a ct scan which did not reveal an etiology for her pain.She was sent to pt 2 to 3 months and was also given exercises and tens unit and claims these did not help with pain.Patient reports having lower abdominal pain and vaginal pain which worsened with activity.Additional symptoms reported included frequency, nocturia, urgency, stress leakage.She also made it clear that she cannot have sex because of the pain.She also had hypersensitivity to any clothing touching the perineal area.Exam revealed cording/rolling of mesh in the paraurethral area and pain upon palpation reproduces left groin and lower abdominal pain, indicative of obturator pain due to tot mesh.There was also vaginal apex pain noted as due to sacrocolpopexy or hysterectomy.Recommendations include vaginal mesh sling revision/removal as well as exploration of both groins given her severe inner thigh pain and radiating pain bilaterally, and vaginal reconstruction.On (b)(6), 2020, patient reports insomnia, migraine, muscle spasms, nausea and neuropathy of the leg.On (b)(6), 2020, the following procedures were performed: -tot sling removal transvaginally.-tot sling removal from both groins bilaterally.-laparoscopic removal of sacrocolpopexy mesh.-laparoscopic adhesiolysis/enterolysis.-laparoscopic uterosacral ligament suspension.-laparoscopic paravaginal repair.-laparoscopic burch urethropexy.-suprapubic catheter placement.-posterior repair.Postoperative diagnoses include: -pelvic pain.-right lower quadrant pain and left lower quadrant pain.-right upper quadrant pain.-history of adhesions.-history of tot sling.-left medial thigh pain.-left groin pain.-history of laparoscopic sacrocolpopexy.-cystocele.-vaginal vault prolapse.-rectocele.-stress urinary incontinence.-severe pelvic scar tissue.On (b)(6), 2021, patient sought consult with a pelvic pain specialist via telemedicine.The patient reported some improvement in her pain after mesh removal, but significant left-sided groin and nerve type pain remained.Additional treatments have included ganglion block without improvement, fentanyl patch, lyrica, and soma.She has significant pain with intercourse that has led to not having any intercourse at all.She also was experiencing significant pain with bowel movement.Her vulvar and perineal hypersensitivity to touch was severe, her tailbone hurt, she had significant urinary hesitancy, and she has not been able to work as her job requires standing for long periods of time.Assessment include spastic pelvic floor syndrome, other specified complications due to genitourinary prosthetic materials, sequelae, and pudendal nerve neuropathy.Patient was planned for the following interventions: -bilateral pudendal nerve block.-botox injection to pelvic floor muscles.-valium 5gm/baclofen 4mg ketamine 15mg suppositories.-pt consult.-may be a candidate for robotic laparoscopic neurolysis of left obturator nerve.-will need bilateral ct guided nerve block with steroids and local anesthetic.-additional information received on march 30, 2022 and april 8, 2022- the patient had an office visit on (b)(6), 2018 and reported that in (b)(6) she had tah-bso (total abdominal hysterectomy and bilateral salpingo-oophorectomy) surgery.Ever since she had diffuse pain and relative constipation and the symptoms had been constant.Had a follow-up ct abdomen but negative by report.The patient was given ppi (proton pump inhibitors), carafate and bentyl but no improvement.There was also no relief with bowel movement, any movement is worse but not in postprandial.Per the assessment, she was diagnosed with generalized abdominal pain - post hyst pain with constant diffuse pain and bloat.Colonoscopy and esophagogastroduodenoscopy were requested.The patient was prescribed nortriptyline 10mg capsule for a tca trial for neuropathic pain syndrome.Assessment from primary care records on march 8, 2021 showed the following problems: * s/p hysterectomy.* generalized abdominal pain.* abdominal cramping.* numbness and tingling.* h/o: hysterectomy.* uti (urinary tract infection).* bladder disorder.Medication changes to sulfamethoxazole-trimethoprim 800-160 mg oral tablet.Discussion/summary: * 1 status post hysterectomy am wondering if it could be adhesions in the area we will get a follow-up with urogynecology * possible bladder disorder with mesh removal from sling procedure follow-up with urology and urogynecology * irritable bowel syndrome has seen gastroenterology in the past colonoscopy egd * at this point she is got any pain management referred to another pain management physician.She lives about an hour and has to wait likewise to gastroenterology and urogynecology.First she has a urinary tract infection, today she has been on cipro levothyroxine and macrodantin.We will check for culture but start on sulfa.On (b)(6), 2021, urinalysis showed a urinary tract infection, and the culture results were escherichia coli (abnormal).On (b)(6), 2022, the patient had a return visit due to pelvic pain.She still continued to have pain and would like to discuss options.The assessment included spastic pelvic floor syndrome; other specified complications due to other genitourinary prosthetic materials, sequela; and pudendal nerve neuropathy disorder.The patient was taking valium 5mg tablet, flouxetine 40mg capsule, zofran 4mg tablet, fentanyl 25mcg/hr transdermal patch and lyrica 75mg capsule.Operative report from mesh removal states that another y-mesh was placed to suspend vagina; however, the physician noted that it was very unlikely that mesh was placed after it was just removed.Operative record review with the surgeon confirmed that no other sacrocolpopexy mesh was placed, and the surgeon indicated he would amend the operative report.Patient would still like to proceed with robotic procedure and decompression of right and left obturator nerves with possible adhesiolysis but no mesh removal.If there is any mesh found it will be removed at the time of surgery.The patient had a follow up visit on (b)(6), 2021 for pelvic pain.She looked so much better than the previous month.She still had pelvic pain, but with medical management and ganglion impar blocks her pain went from an 8 to a 10/10 to a 4 out of 10.The ganglion impar block and duragesic patch had just started to workand together had improved her pain by about 70 percent.Breakthrough pain is more frequent than bid, so long-acting medication was increased.The assessment showed that the patient had perineal pain and chronic pelvic pain post mesh surgeries.Plan: 1.Increase duragesic to 50 meg/hour.2.Continue breakthrough bid.3.Can repeat gi either la/steroid or rf if she wishes.4.Rtc in 3 months for medication management.5.Oxycodone and fentanyl today for 1 month however she will need 2 months after that in arizona.6.She would like a repeat of her ganglion impar block when she returns in 3 months.As the pain still continued after the mesh was removed including the arms, the patient went to see a surgeon on (b)(6), 2022, and had a discussion to proceed with bilateral pudendal nerve block and botox injection to pelvic floor muscles.On (b)(6), 2022, the patient underwent robotic assisted laparoscopic removal of small portion of sacrocolpopexy mesh, bilateral pudendal nerve block, botox injection to pelvic floor muscles (8 muscles injected), and robotic bilateral obturator neurolysis.Prior to the procedure, the patient was diagnosed with pelvic pain, complication of pelvic mesh, obturator neuralgia, and spastic pelvic floor syndrome.Findings included bilateral spasm of pelvic floor muscles, ethibond sutures attached to the vaginal apex on both sides and ipsilateral uterosacral ligaments, approximately 2cm piece of mesh attached to the sacral promontory, the left obturator nerve was without scar tissue, and there was a band of scar tissue pressing on the right obturator nerve inferior (posterior) to the nerve.During the robotic removal of sacral attachment of mesh, adhesions of the rectum and vagina to the pelvic floor and bladder were taken down using sharp and blunt dissection.Sacral promontory was examined and there was approximately 2 cm of blue colored mesh attached to the anterior ligament.They were carefully dissected out and cut.Remainder of sacrocolpopexy mesh was then removed and send to pathology.Patient was taken to the recovery room in stable condition.

Manufacturer Narrative

Additional information: blocks a5, a6, b5, d6b, h6: patient codes and impact codes.Block b3 date of event: date of event was approximated to june 12, 2018, date symptoms initially reported during a clinic visit, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Surgeon for complete mesh removal is: dr.(b)(6).Block h6: patient codes e2330, e1002, e2333, e1405, e0130, e0116, e1605, e1020, e0126, e2101, e1715, e1901, e0402, e0123, e0127 and e1310 capture the reportable event of pelvic and groin pain, abdominal pain, pelvic organ prolapse, dyspareunia, insomnia, migraine, muscle spasms, nausea, neuropathy, adhesions, scar tissue, vaginosis, hypersensitivity, nerve damage and numbness and uti.Impact codes f19, f2303, f1202, f1903 and f1204 capture the reportable event of mesh removal, medications required to control pain and not being able to work, pain continued after the first mesh removal and removal of the remaining 2cm piece of mesh.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

This manufacturer report pertains to the second of two devices used during the same procedure.It was reported to boston scientific corporation that an upsylon y-mesh and an obtryx ii system - halo were implanted into the patient during a procedure performed on (b)(6) 2018.As reported by the patient's attorney, the patient has experienced an unspecified injury.Additional information received on 14jan2022.It was reported that the patient has a history of pelvic organ prolapse, urge incontinence, as well as uterine leiomyoma.Pre-op diagnosis includes stress urinary incontinence.On (b)(6) 2018, a robotic-assisted hysterectomy was performed, followed by robotic-assisted laparoscopic sacrocolpopexy and synthetic mid-urethral sling obturator and cystourethroscopy.The procedure was tolerated well without complications.On june 12, 2018, patient reports experiencing stress incontinence (when she bends over and bladder is full, but better than before surgery), urge incontinence (but improved from prior to surgery) and urgency.She also reports some tail bone pain which only started two weeks ago.She reports she cannot sit for prolonged periods of time.She does report some lower abdominal pain intermittently and suprapubic pressure, but this is all improving.She also had some upper abdominal cramps which is essentially resolved.Exam revealed grade 2 rectocele, normal vaginal mucosa, and no mesh erosions.Urinalysis was normal and postvoid residual (pvr) was 31 ml.The impression included rectocele, minimal stress incontinence for which she was having pelvic floor physical therapy (pfpt), urge incontinence for which the patient was to resume myrbetriq, and vaginosis for which the patient was to start metrogel vaginally.On (b)(6) 2018, patient presented for perimenopausal/menopausal symptoms post-hysterectomy.She also reported pelvic pain characterized as crampy, intermittent, severe, radiating to the back, aggravated by physical activity.Note: pain is improving, she has regained her multiple orgasm status and is happy about this.Exam was consistent with pelvic floor/levator tenderness and tight muscles.The patient was taught pelvic floor relaxation techniques.On (b)(6) 2020, patient presents with complaints of mesh complication, lower abdominal pain, pelvic and groin pain and lower back pain.Patient states her problems started after the surgery she had which included an lavh, sc and sling.Seven weeks post-op she had a ct scan which did not reveal an etiology for her pain.She was sent to pt 2 to 3 months and was also given exercises and tens unit and claims these did not help with pain.Patient reports having lower abdominal pain and vaginal pain which worsened with activity.Additional symptoms reported included frequency, nocturia, urgency, stress leakage.She also made it clear that she cannot have sex because of the pain.She also had hypersensitivity to any clothing touching the perineal area.Exam revealed cording/rolling of mesh in the paraurethral area and pain upon palpation reproduces left groin and lower abdominal pain, indicative of obturator pain due to tot mesh.There was also vaginal apex pain noted as due to sacrocolpopexy or hysterectomy.Recommendations include vaginal mesh sling revision/removal as well as exploration of both groins given her severe inner thigh pain and radiating pain bilaterally, and vaginal reconstruction.On (b)(6) 2020, patient reports insomnia, migraine, muscle spasms, nausea and neuropathy of the leg.On (b)(6) 2020, the following procedures were performed: -tot sling removal transvaginally.-tot sling removal from both groins bilaterally.-laparoscopic removal of sacrocolpopexy mesh.-laparoscopic adhesiolysis/enterolysis.-laparoscopic uterosacral ligament suspension.-laparoscopic paravaginal repair.-laparoscopic burch urethropexy.-suprapubic catheter placement.-posterior repair.Postoperative diagnoses include: -pelvic pain.-right lower quadrant pain and left lower quadrant pain.-right upper quadrant pain.-history of adhesions.-history of tot sling.-left medial thigh pain.-left groin pain.-history of laparoscopic sacrocolpopexy.-cystocele.-vaginal vault prolapse.-rectocele.-stress urinary incontinence.-severe pelvic scar tissue.On (b)(6) 2021, patient sought consult with a pelvic pain specialist via telemedicine.The patient reported some improvement in her pain after mesh removal, but significant left-sided groin and nerve type pain remained.Additional treatments have included ganglion block without improvement, fentanyl patch, lyrica, and soma.She has significant pain with intercourse that has led to not having any intercourse at all.She also was experiencing significant pain with bowel movement.Her vulvar and perineal hypersensitivity to touch was severe, her tailbone hurt, she had significant urinary hesitancy, and she has not been able to work as her job requires standing for long periods of time.Assessment include spastic pelvic floor syndrome, other specified complications due to genitourinary prosthetic materials, sequelae, and pudendal nerve neuropathy.Patient was planned for the following interventions: -bilateral pudendal nerve block.-botox injection to pelvic floor muscles.-valium 5gm/baclofen 4mg/ketamine 15mg suppositories.-pt consult.-may be a candidate for robotic laparoscopic neurolysis of left obturator nerve.-will need bilateral ct guided nerve block with steroids and local anesthetic.The device is not expected to be returned.Additional information received on march 30, 2022 and april 8, 2022.The patient had an office visit on (b)(6) 2018 and reported that in april she had tah-bso (total abdominal hysterectomy and bilateral salpingo-oophorectomy) surgery.Ever since she had diffuse pain and relative constipation and the symptoms had been constant.Had a follow-up ct abdomen but negative by report.The patient was given ppi (proton pump inhibitors), carafate and benty but no improvement.There was also no relief with bowel movement, any movement is worse but not in postprandial.Per the assessment, she was diagnosed with generalized abdominal pain - post hyst pain with constant diffuse pain and bloat.Colonoscopy and esophagogastroduodenoscopy were requested.The patient was taking nortriptyline 10mg capsule.Assessment on (b)(6) 2021 showed the following problems: * s/p hysterectomy.* generalized abdominal pain.* abdominal cramping.* numbness and tingling.* mild cognitive impairment.* h/o: hysterectomy.* uti (urinary tract infection).* bladder disorder.Medication changes to sulfamethoxazole-trimethoprim 800-160 mg oral tablet.Discussion/summary: * 1 status post hysterectomy am wondering if it could be adhesions in the area we will get a follow-up with urogynecology.* possible bladder disorder with mesh removal from sling procedure follow-up with urology and urogynecology.* irritable bowel syndrome has seen gastroenterology in the past colonoscopy egd.* at this point she is got any pain management referred to another pain management physician.She lives about an hour and has to wait likewise to gastroenterology and urogynecology.First she has a urinary tract infection, today she has been on cipro levothyroxine and macrodantin.We will check for culture but start on sulfa.On (b)(6) 2021, the patient underwent the following tests namely urinalysis complete with microscopic: appearance cloudy (abnormal), leukocyte esterase (abnormal), bacteria - many (abnormal), urine culture, routine: final report (abnormal), escherichia coli (abnormal).On february 14, 2022, the patient had a return visit due to pelvic pain.She still continued to have pain and would like to discuss options.The assessment showed spastic pelvic floor syndrome; other specified complications due to other genitournary prosthetic materials, sequela; and pudendal nerve neuropathy disorder.The patient was taking valium 5mg tablet, flouxetine 40mg capsule, zofran 4mg tablet, fentanyl 25mcg/hr transdermal patch and lyrica 75mg capsule.Operative report from mesh removal states that another y-mesh was placed to suspend vagina; however, during another visit on (b)(6) 2022, the physician finds it very unlikely that mesh was placed after it was just removed.Looking at the records, it was confirmed that there was no other sacrocolpopexy mesh that actually placed.Patient would still like to proceed with robotic procedure and decompression of right and left obturator nerves with possible adhesiolysis but no mesh removal.If there is any mesh found it will be removed at the time of surgery.The patient had a follow up visit on november 9, 2021 for pelvic pain.She looks so much better today than last month.Her pain is still in the pelvis, but with medical management and ganglion impar blocks her pain went from an 8 to a 10/10 today out of 4 out of 10.The ganglion impar block and duragesic patch have just started to work.The two combined has improved her pain by about 70 percent.Breakthrough pain is more frequent than bid, so long acting medication will be increased.The assessment showed that the patient had perineal pain and chronic pelvic pain post mesh surgeries.Plan: 1.Increase duragesic to 50 meg/hour.2.Continue breakthrough bid.3.Can repeat gi either la/steroid or rf if she wishes.4.Rtc in 3 months for medication management.5.Oxycodone and fentanyl today for 1 month however she will need 2 months after that in arizona.6.She would like a repeat of her ganglion impar block when she returns in 3 months.As the pain still continued after the mesh was removed including the arms, the patient went to see a surgeon on (b)(6) 2022, and had a discussion to proceed with bilateral pudendal nerve block and botox injection to pelvic floor muscles.Eventually, on (b)(6) 2022, the patient had the planned surgery including the removal of the remaining mesh.She underwent robotic assisted laparoscopic removal of small portion of sacrocolpopexy mesh, bilateral pudendal nerve block, botox injection to pelvic floor muscles (8 muscles injected), and robotic bilateral obturator neurolysis.Prior to the procedure, the patient was diagnosed with pelvic pain, complication of pelvic mesh, obturator neuralgia, and spastic pelvic floor syndrome.During the robotic removal of sacral attachment of mesh, adhesions of the rectum and vagina to the pelvic floor and bladder were taken down using sharp and blunt dissection.Sacral promontory was examined and there was approximately 2 cm of blue colored mesh attached to the anterior ligament.They were carefully dissected out and cut.Remainder of sacrocolpopexy mesh was then removed and send to pathology.Patient was taken to the recovery room in stable condition.Additional information received on june 28, 2022.On physical examination on (b)(6) 2020, a golf ball-sized bulge descended to hymenal ring and bulged anteriorly was noted.It was also discovered that the patient had weak bulbocavernosus reflex and weak anal wink.The patient was also reported to experience urethral hypermobility, night sweats, tiredness/fatigue, frequent vomiting, blood in stool and joint pain, joint swelling and joint stiffness.On (b)(6), 2020, the patient had cystoscopy which showed a normal bladder.Additional information received on july 28, 2022.An office visit on (b)(6) 2021, the patient reported a history of continued pelvic pain that radiates to her left leg and makes sitting for periods of time difficult.Had a recent history of uti that was treated, but she still felt some burning with urination.She reported having a sling surgery and stress incontinence is mild at this time.She had used compounded vaginal suppositories for pelvic pain that are helpful.She will bring her rx for refills.She has been on pellet hormone therapy in the past and would like to continue.Last pellets was june 2021.Gu: culture today for pain with urination.Last uti early 2021, e.Coll.G!: intermittent constipation.Gyn: sexually active with dyspareunia.Assessment: 1.Lower urinary tract infection.2.Pelvic pain, follow up with a consultant and await lab result.Urine culture: culture shows less than 10,000 colony forming units or bacterial per milliliter of urine.This colony count is not generally considered to be clinically significant.Clean - catch.

Manufacturer Narrative

Additional information: date of event: date of event was approximated to june 12, 2018, date symptoms initially reported during a clinic visit, as no event date was reported.Block e1: (b)(6).Block h6: patient codes e2330, e1002, e2333, e1405, e0130, e0116, e1605, e1020, e0126, e2101, e1715, e1901, e0402, e0123, e0127 and e1310 capture the reportable event of pelvic and groin pain, abdominal pain, pelvic organ prolapse, dyspareunia, insomnia, migraine, muscle spasms, nausea, neuropathy, adhesions, scar tissue, vaginosis, hypersensitivity, nerve damage and numbness and uti.Impact codes f19, f2303, f1202, f1903 and f1204 capture the reportable event of mesh removal, medications required to control pain and not being able to work, pain continued after the first mesh removal and removal of the remaining 2cm piece of mesh.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 problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Manufacturer Narrative

Additional information: blocks b5 and h6: patient codes.Block b3 date of event: date of event was approximated to june 12, 2018, date symptoms initially reported during a clinic visit, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6) md.(b)(6) medical center.(b)(6).Surgeon for complete mesh removal is: dr.(b)(6).(b)(6) medical center, (b)(6).Block h6: patient codes e2330, e1002, e2333, e1405, e0130, e0116, e1605, e1020, e0126, e2101, e1715, e1901, e0402, e0123, e0127 and e1310 capture the reportable event of pelvic and groin pain, abdominal pain, pelvic organ prolapse, dyspareunia, insomnia, migraine, muscle spasms, nausea, neuropathy, adhesions, scar tissue, vaginosis, hypersensitivity, nerve damage and numbness and uti.Impact codes f19, f2303, f1202, f1903 and f1204 capture the reportable event of mesh removal, medications required to control pain and not being able to work, pain continued after the first mesh removal and removal of the remaining 2cm piece of mesh.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 problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Note: this manufacturer report pertains to the second of two devices used during the same procedure.It was reported to boston scientific corporation that an upsylon y-mesh and an obtryx ii system - halo were implanted into the patient during a procedure performed on (b)(6) 2018.As reported by the patient's attorney, the patient has experienced an unspecified injury.Additional information received on 14jan2022.It was reported that the patient has a history of pelvic organ prolapse, urge incontinence, as well as uterine leiomyoma.Pre-op diagnosis includes stress urinary incontinence.On (b)(6) 2018, a robotic-assisted hysterectomy was performed, followed by robotic-assisted laparoscopic sacrocolpopexy and synthetic mid-urethral sling obturator and cystourethroscopy.The procedure was tolerated well without complications.On (b)(6) 2018, patient reports experiencing stress incontinence (when she bends over and bladder is full, but better than before surgery), urge incontinence (but improved from prior to surgery) and urgency.She also reports some tail bone pain which only started two weeks ago.She reports she cannot sit for prolonged periods of time.She does report some lower abdominal pain intermittently and suprapubic pressure, but this is all improving.She also had some upper abdominal cramps which is essentially resolved.Exam revealed grade 2 rectocele, normal vaginal mucosa, and no mesh erosions.Urinalysis was normal and postvoid residual (pvr) was 31 ml.The impression included rectocele, minimal stress incontinence for which she was having pelvic floor physical therapy (pfpt), urge incontinence for which the patient was to resume myrbetriq, and vaginosis for which the patient was to start metrogel vaginally.On (b)(6) 2018, patient presented for perimenopausal/menopausal symptoms post-hysterectomy.She also reported pelvic pain characterized as crampy, intermittent, severe, radiating to the back, aggravated by physical activity.Note: pain is improving, she has regained her multiple orgasm status and is happy about this.Exam was consistent with pelvic floor/levator tenderness and tight muscles.The patient was taught pelvic floor relaxation techniques.On (b)(6) 2020, patient presents with complaints of mesh complication, lower abdominal pain, pelvic and groin pain and lower back pain.Patient states her problems started after the surgery she had which included an lavh, sc and sling.Seven weeks post-op she had a ct scan which did not reveal an etiology for her pain.She was sent to pt 2 to 3 months and was also given exercises and tens unit and claims these did not help with pain.Patient reports having lower abdominal pain and vaginal pain which worsened with activity.Additional symptoms reported included frequency, nocturia, urgency, stress leakage.She also made it clear that she cannot have sex because of the pain.She also had hypersensitivity to any clothing touching the perineal area.Exam revealed cording/rolling of mesh in the paraurethral area and pain upon palpation reproduces left groin and lower abdominal pain, indicative of obturator pain due to tot mesh.There was also vaginal apex pain noted as due to sacrocolpopexy or hysterectomy.Recommendations include vaginal mesh sling revision/removal as well as exploration of both groins given her severe inner thigh pain and radiating pain bilaterally, and vaginal reconstruction.On (b)(6) 2020, patient reports insomnia, migraine, muscle spasms, nausea and neuropathy of the leg.On (b)(6) 2020, the following procedures were performed: -tot sling removal transvaginally.-tot sling removal from both groins bilaterally.-laparoscopic removal of sacrocolpopexy mesh.-laparoscopic adhesiolysis/enterolysis.-laparoscopic uterosacral ligament suspension.-laparoscopic paravaginal repair.-laparoscopic burch urethropexy.-suprapubic catheter placement.-posterior repair.Postoperative diagnoses include: -pelvic pain.-right lower quadrant pain and left lower quadrant pain.-right upper quadrant pain.-history of adhesions.-history of tot sling.-left medial thigh pain.-left groin pain.-history of laparoscopic sacrocolpopexy.-cystocele.Vaginal vault prolapse.-rectocele.-stress urinary incontinence.-severe pelvic scar tissue.On (b)(6) 2021, patient sought consult with a pelvic pain specialist via telemedicine.The patient reported some improvement in her pain after mesh removal, but significant left-sided groin and nerve type pain remained.Additional treatments have included ganglion block without improvement, fentanyl patch, lyrica, and soma.She has significant pain with intercourse that has led to not having any intercourse at all.She also was experiencing significant pain with bowel movement.Her vulvar and perineal hypersensitivity to touch was severe, her tailbone hurt, she had significant urinary hesitancy, and she has not been able to work as her job requires standing for long periods of time.Assessment include spastic pelvic floor syndrome, other specified complications due to genitourinary prosthetic materials, sequelae, and pudendal nerve neuropathy.Patient was planned for the following interventions: -bilateral pudendal nerve block.-botox injection to pelvic floor muscles -valium 5gm/baclofen 4mg/ketamine 15mg suppositories.-pt consult -may be a candidate for robotic laparoscopic neurolysis of left obturator nerve.-will need bilateral ct guided nerve block with steroids and local anesthetic.The device is not expected to be returned.Additional information received on march 30, 2022 and april 8, 2022.The patient had an office visit on (b)(6) 2018 and reported that in april she had tah-bso (total abdominal hysterectomy and bilateral salpingo-oophorectomy) surgery.Ever since she had diffuse pain and relative constipation and the symptoms had been constant.Had a follow-up ct abdomen but negative by report.The patient was given ppi (proton pump inhibitors), carafate and benty but no improvement.There was also no relief with bowel movement, any movement is worse but not in postprandial.Per the assessment, she was diagnosed with generalized abdominal pain - post hyst pain with constant diffuse pain and bloat.Colonoscopy and esophagogastroduodenoscopy were requested.The patient was taking nortriptyline 10mg capsule.Assessment on march 8, 2021 showed the following problems: s/p hysterectomy.Generalized abdominal pain.Abdominal cramping.Numbness and tingling.Mild cognitive impairment.H/o: hysterectomy.Uti (urinary tract infection).Bladder disorder.Medication changes to sulfamethoxazole-trimethoprim 800-160 mg oral tablet.Discussion/summary: 1 status post hysterectomy am wondering if it could be adhesions in the area we will get a follow-up with urogynecology.Possible bladder disorder with mesh removal from sling procedure follow-up with urology and urogynecology.Irritable bowel syndrome has seen gastroenterology in the past colonoscopy egd.At this point she is got any pain management referred to another pain management physician.She lives about an hour and has to wait likewise to gastroenterology and urogynecology.First she has a urinary tract infection, today she has been on cipro levothyroxine and macrodantin.We will check for culture but start on sulfa.On (b)(6) 2021, the underwent the following tests namely urinalysis complete with microscopic: appearance cloudy (abnormal), leukocyte esterase (abnormal), bacteria - many (abnormal), urine culture, routine: final report (abnormal), escherichia coli (abnormal).On (b)(6) 2022, the patient had a return visit due to pelvic pain.She still continued to have pain and would like to discuss options.The assessment showed spastic pelvic floor syndrome; other specified complications due to other genitournary prosthetic materials, sequela; and pudendal nerve neuropathy disorder.The patient was taking valium 5mg tablet, flouxetine 40mg capsule, zofran 4mg tablet, fentanyl 25mcg/hr transdermal patch and lyrica 75mg capsule.Operative report from mesh removal states that another y-mesh was placed to suspend vagina; however, during another visit on (b)(6) 2022, the physician finds it very unlikely that mesh was placed after it was just removed.Looking at the records, it was confirmed that there was no other sacrocolpopexy mesh that actually placed.Patient would still like to proceed with robotic procedure and decompression of right and left obturator nerves with possible adhesiolysis but no mesh removal.If there is any mesh found it will be removed at the time of surgery.The patient had a follow up visit on (b)(6) 2021 for pelvic pain.She looks so much better today than last month.Her pain is still in the pelvis, but with medical management and ganglion impar blocks her pain went from an 8 to a 10/10 today out of 4 out of 10.The ganglion impar block and duragesic patch have just started to work.The two combined has improved her pain by about 70 percent.Breakthrough pain is more frequent than bid, so long acting medication will be increased.The assessment showed that the patient had perineal pain and chronic pelvic pain post mesh surgeries.Plan: 1.Increase duragesic to 50 meg/hour.2.Continue breakthrough bid.3.Can repeat gi either la/steroid or rf if she wishes.4.Rtc in 3 months for medication management.5.Oxycodone and fentanyl today for 1 month however she will need 2 months after that in arizona.6.She would like a repeat of her ganglion impar block when she returns in 3 months.As the pain still continued after the mesh was removed including the arms, the patient went to see a surgeon on (b)(6) 2022, and had a discussion to proceed with bilateral pudendal nerve block and botox injection to pelvic floor muscles.Eventually, on (b)(6) 2022, the patient had the planned surgery including the removal of the remaining mesh.She underwent robotic assisted laparoscopic removal of small portion of sacrocolpopexy mesh, bilateral pudendal nerve block, botox injection to pelvic floor muscles (8 muscles injected), and robotic bilateral obturator neurolysis.Prior to the procedure, the patient was diagnosed with pelvic pain, complication of pelvic mesh, obturator neuralgia, and spastic pelvic floor syndrome.During the robotic removal of sacral attachment of mesh, adhesions of the rectum and vagina to the pelvic floor and bladder were taken down using sharp and blunt dissection.Sacral promontory was examined and there was approximately 2 cm of blue colored mesh attached to the anterior ligament.They were carefully dissected out and cut.Remainder of sacrocolpopexy mesh was then removed and send to pathology.Patient was taken to the recovery room in stable condition.Additional information received on june 28, 2022.On physical examination on (b)(6) 2020, a golf ball-sized bulge descended to hymenal ring and bulged anteriorly was noted.It was also discovered that the patient had weak bulbocavernosus reflex and weak anal wink.The patient was also reported to experience urethral hypermobility, night sweats, tiredness/fatigue, frequent vomiting, blood in stool and joint pain, joint swelling and joint stiffness.On (b)(6) 2020, the patient had cystoscopy which showed a normal bladder.

Manufacturer Narrative

Additional information: blocks b5 and h6: patient codes have been updated based on the additional information received on august 2, 2023.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6) md.(b)(6).Surgeon for complete mesh removal is: dr.(b)(6).(b)(6) medical center, (b)(6).Block h6: imdrf patient codes e2330, e1002, e2333, e1405, e0130, e0116, e1605, e1020, e0126, e2101, e1715, e1901, e0402, e0123, e0127, e1310 and e0206 capture the reportable event of pelvic and groin pain, abdominal pain, pelvic organ prolapse, dyspareunia, insomnia, migraine, muscle spasms, nausea, neuropathy, adhesions, scar tissue, vaginosis, hypersensitivity, nerve damage and numbness, uti, and mental distress.Imdrf impact codes f19, f2303, f1202, f1903 and f1204 capture the reportable event of mesh removal, medications required to control pain and not being able to work, pain continued after the first mesh removal and removal of the remaining 2cm piece of mesh.

Event Description

Note: this manufacturer report pertains to the second of two devices used during the same procedure.It was reported to boston scientific corporation that an upsylon y-mesh and an obtryx ii system - halo were implanted into the patient during a procedure performed on (b)(6) 2018.As reported by the patient's attorney, the patient has experienced an unspecified injury.Additional information received on 14jan2022: it was reported that the patient has a history of pelvic organ prolapse, urge incontinence, as well as uterine leiomyoma.Pre-op diagnosis includes stress urinary incontinence.On (b)(6) 2018, a robotic-assisted hysterectomy was performed, followed by robotic-assisted laparoscopic sacrocolpopexy and synthetic mid-urethral sling obturator and cystourethroscopy.The procedure was tolerated well without complications.On (b)(6) 2018, patient reports experiencing stress incontinence (when she bends over and bladder is full, but better than before surgery), urge incontinence (but improved from prior to surgery) and urgency.She also reports some tail bone pain which only started two weeks ago.She reports she cannot sit for prolonged periods of time.She does report some lower abdominal pain intermittently and suprapubic pressure, but this is all improving.She also had some upper abdominal cramps which is essentially resolved.Exam revealed grade 2 rectocele, normal vaginal mucosa, and no mesh erosions.Urinalysis was normal and postvoid residual (pvr) was 31 ml.The impression included rectocele, minimal stress incontinence for which she was having pelvic floor physical therapy (pfpt), urge incontinence for which the patient was to resume myrbetriq, and vaginosis for which the patient was to start metrogel vaginally.On (b)(6) 2018, patient presented for perimenopausal/menopausal symptoms post-hysterectomy.She also reported pelvic pain characterized as crampy, intermittent, severe, radiating to the back, aggravated by physical activity.Note: pain is improving, she has regained her multiple orgasm status and is happy about this.Exam was consistent with pelvic floor/levator tenderness and tight muscles.The patient was taught pelvic floor relaxation techniques.On (b)(6) 2020, patient presents with complaints of mesh complication, lower abdominal pain, pelvic and groin pain and lower back pain.Patient states her problems started after the surgery she had which included an lavh, sc and sling.Seven weeks post-op she had a ct scan which did not reveal an etiology for her pain.She was sent to pt 2 to 3 months and was also given exercises and tens unit and claims these did not help with pain.Patient reports having lower abdominal pain and vaginal pain which worsened with activity.Additional symptoms reported included frequency, nocturia, urgency, stress leakage.She also made it clear that she cannot have sex because of the pain.She also had hypersensitivity to any clothing touching the perineal area.Exam revealed cording/rolling of mesh in the paraurethral area and pain upon palpation reproduces left groin and lower abdominal pain, indicative of obturator pain due to tot mesh.There was also vaginal apex pain noted as due to sacrocolpopexy or hysterectomy.Recommendations include vaginal mesh sling revision/removal as well as exploration of both groins given her severe inner thigh pain and radiating pain bilaterally, and vaginal reconstruction.On (b)(6) 2020, patient reports insomnia, migraine, muscle spasms, nausea and neuropathy of the leg.On (b)(6) 2020, the following procedures were performed: tot sling removal transvaginally.Tot sling removal from both groins bilaterally.Laparoscopic removal of sacrocolpopexy mesh.Laparoscopic adhesiolysis/enterolysis.Laparoscopic uterosacral ligament suspension.Laparoscopic paravaginal repair.Laparoscopic burch urethropexy.Suprapubic catheter placement.Posterior repair.Postoperative diagnoses include: pelvic pain.Right lower quadrant pain and left lower quadrant pain.Right upper quadrant pain.History of adhesions.History of tot sling.Left medial thigh pain.Left groin pain.History of laparoscopic sacrocolpopexy.Cystocele.Vaginal vault prolapse.Rectocele.Stress urinary incontinence.Severe pelvic scar tissue.On (b)(6) 2021, patient sought consult with a pelvic pain specialist via telemedicine.The patient reported some improvement in her pain after mesh removal, but significant left-sided groin and nerve type pain remained.Additional treatments have included ganglion block without improvement, fentanyl patch, lyrica, and soma.She has significant pain with intercourse that has led to not having any intercourse at all.She also was experiencing significant pain with bowel movement.Her vulvar and perineal hypersensitivity to touch was severe, her tailbone hurt, she had significant urinary hesitancy, and she has not been able to work as her job requires standing for long periods of time.Assessment include spastic pelvic floor syndrome, other specified complications due to genitourinary prosthetic materials, sequelae, and pudendal nerve neuropathy.Patient was planned for the following interventions: bilateral pudendal nerve block.Botox injection to pelvic floor muscles.Valium 5gm/baclofen 4mg/ketamine 15mg suppositories.Pt consult.May be a candidate for robotic laparoscopic neurolysis of left obturator nerve.Will need bilateral ct guided nerve block with steroids and local anesthetic.The device is not expected to be returned.Additional information received on march 30, 2022 and april 8, 2022; the patient had an office visit on (b)(6) 2018 and reported that in april she had tah-bso (total abdominal hysterectomy and bilateral salpingo-oophorectomy) surgery.Ever since she had diffuse pain and relative constipation and the symptoms had been constant.Had a follow-up ct abdomen but negative by report.The patient was given ppi (proton pump inhibitors), carafate and benty but no improvement.There was also no relief with bowel movement, any movement is worse but not in postprandial.Per the assessment, she was diagnosed with generalized abdominal pain - post hyst pain with constant diffuse pain and bloat.Colonoscopy and esophagogastroduodenoscopy were requested.The patient was taking nortriptyline 10mg capsule.Assessment on (b)(6) 2021 showed the following problems: s/p hysterectomy.Generalized abdominal pain.Abdominal cramping.Numbness and tingling.Mild cognitive impairment.H/o: hysterectomy.Uti (urinary tract infection).Bladder disorder.Medication changes to sulfamethoxazole-trimethoprim 800-160 mg oral tablet.Discussion/summary: 1 status post hysterectomy am wondering if it could be adhesions in the area we will get a follow-up; with urogynecology, possible bladder disorder with mesh removal from sling procedure follow-up with urology and urogynecology irritable bowel syndrome has seen gastroenterology in the past colonoscopy egd at this point she is got any pain management referred to another pain management physician.She lives about an hour and has to wait likewise to gastroenterology and urogynecology.First she has a urinary tract infection, today she has been on cipro levothyroxine and macrodantin.We will check for culture but start on sulfa.On (b)(6) 2021, the patient underwent the following tests namely urinalysis complete with microscopic: appearance cloudy (abnormal), leukocyte esterase (abnormal), bacteria - many (abnormal), urine culture, routine: final report (abnormal), escherichia coli (abnormal).On (b)(6) 2022, the patient had a return visit due to pelvic pain.She still continued to have pain and would like to discuss options.The assessment showed spastic pelvic floor syndrome; other specified complications due to other genitournary prosthetic materials, sequela; and pudendal nerve neuropathy disorder.The patient was taking valium 5mg tablet, flouxetine 40mg capsule, zofran 4mg tablet, fentanyl 25mcg/hr transdermal patch and lyrica 75mg capsule.Operative report from mesh removal states that another y-mesh was placed to suspend vagina; however, during another visit on (b)(6) 2022, the physician finds it very unlikely that mesh was placed after it was just removed.Looking at the records, it was confirmed that there was no other sacrocolpopexy mesh that actually placed.Patient would still like to proceed with robotic procedure and decompression of right and left obturator nerves with possible adhesiolysis but no mesh removal.If there is any mesh found it will be removed at the time of surgery.The patient had a follow up visit on (b)(6) 2021 for pelvic pain.She looks so much better today than last month.Her pain is still in the pelvis, but with medical management and ganglion impar blocks her pain went from an 8 to a 10/10 today out of 4 out of 10.The ganglion impar block and duragesic patch have just started to work.The two combined has improved her pain by about 70 percent.Breakthrough pain is more frequent than bid, so long acting medication will be increased.The assessment showed that the patient had perineal pain and chronic pelvic pain post mesh surgeries.Plan: 1.Increase duragesic to 50 meg/hour.2.Continue breakthrough bid.3.Can repeat gi either la/steroid or rf if she wishes.4.Rtc in 3 months for medication management.5.Oxycodone and fentanyl today for 1 month however she will need 2 months after that in arizona.6.She would like a repeat of her ganglion impar block when she returns in 3 months.As the pain still continued after the mesh was removed including the arms, the patient went to see a surgeon on (b)(6) 2022, and had a discussion to proceed with bilateral pudendal nerve block and botox injection to pelvic floor muscles.Eventually, on (b)(6) 2022, the patient had the planned surgery including the removal of the remaining mesh.She underwent robotic assisted laparoscopic removal of small portion of sacrocolpopexy mesh, bilateral pudendal nerve block, botox injection to pelvic floor muscles (8 muscles injected), and robotic bilateral obturator neurolysis.Prior to the procedure, the patient was diagnosed with pelvic pain, complication of pelvic mesh, obturator neuralgia, and spastic pelvic floor syndrome.During the robotic removal of sacral attachment of mesh, adhesions of the rectum and vagina to the pelvic floor and bladder were taken down using sharp and blunt dissection.Sacral promontory was examined and there was approximately 2 cm of blue colored mesh attached to the anterior ligament.They were carefully dissected out and cut.Remainder of sacrocolpopexy mesh was then removed and send to pathology.Patient was taken to the recovery room in stable condition.Additional information received on june 28, 2022; on physical examination on (b)(6) 2020, a golf ball-sized bulge descended to hymenal ring and bulged anteriorly was noted.It was also discovered that the patient had weak bulbocavernosus reflex and weak anal wink.The patient was also reported to experience urethral hypermobility, night sweats, tiredness/fatigue, frequent vomiting, blood in stool and joint pain, joint swelling and joint stiffness.On (b)(6) 2020, the patient had cystoscopy which showed a normal bladder.Additional information received on july 28, 2022; an office visit on (b)(6) 2021, the patient reported a history of continued pelvic pain that radiates to her left leg and makes sitting for periods of time difficult.Had a recent history of uti that was treated, but she still felt some burning with urination.She reported having a sling surgery and stress incontinence is mild at this time.She had used compounded vaginal suppositories for pelvic pain that are helpful.She will bring her rx for refills.She has been on pellet hormone therapy in the past and would like to continue.Last pellets was (b)(6) 2021.Gu: culture today for pain with urination.Last uti early 2021, e.Coll.G!: intermittent constipation.Gyn: sexually active with dyspareunia.Assessment: 1.Lower urinary tract infection 2.Pelvic pain, follow up with a consultant and await lab result.Urine culture: culture shows less than 10,000 colony forming units or bacterial per milliliter of urine.This colony count is not generally considered to be clinically significant.Clean - catch additional information received on august 2, 2023; on (b)(6) 2022, patient was referred by a physician for evaluation and treatment of pelvic floor nerve pain and muscle damage from mesh.The patient had suffered from this pain since (b)(6) 2018.The pain did radiate thoroughly through left extremities.It was constant, generalized pain as aching, sharp, stabbing, pin/needles and pressure vaginally.The pain was worse with activity, prolonged sitting and standing.It was alleviated with meds, resting and heat.The patient did experience numbness and weakness.Assessments: 1.Opiate analgesic use agreement exists 2.Mental distress 3.Pelvic pain (patient reported outcomes measurement information system) promis-29 computer-administered psychological testing was performed in the office with the following results: 1.Anxiety - score was 75 2.Depression - score 79 3.Fatigue - score was 76 4.Pain interference - score was 76 5.Physical function - score was 29 6.Sleep disturbance - score was 60 7.Ability to participate in social - score was 27 during a phone call on (b)(6) 2018, the patient stated that she had severe abdominal pain since her implant surgery.Her pain was from her pelvic bone to under her breast.Per the patient, she had normal bowel movements.She also stated that she suffered from memory loss since the procedure.She had trouble thinking straight.She sounded medicated or not fully awake on the phone.She stated that she could not do any physical activity, but only laying around.Assessment: 1.Chronic pain syndrome.2.Chronic prescription opiate use.3.Other long term (current) drug therapy.4.Mental distress.5.Opiate analgesic use agreement exists.6.Pelvic pain.7.Other specified complications due to other genitourinary prosthetic materials, sequela.8.Entrapment neuropathy of genitofemoral nerve.9.Other muscle spasm.

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Brand Name

OBTRYX II SYSTEM - HALO

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)

BOSTON SCIENTIFIC CORPORATION

780 brookside drive

spencer IN 47460

Manufacturer Contact

carole morley

300 boston scientific way

marlborough, MA 01752

5086834015

MDR Report Key

10711115

MDR Text Key

212290948

Report Number

3005099803-2020-04584

Device Sequence Number

Product Code

OTN

UDI-Device Identifier

08714729837565

UDI-Public

08714729837565

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

K121754

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Consumer,Company Representative

Reporter Occupation

Other

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

10/21/2020

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Expiration Date

11/29/2020

Device Model Number

M0068505110

Device Catalogue Number

850-511

Device Lot Number

0021452432

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Date Manufacturer Received

08/02/2023

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Date Device Manufactured

11/30/2017

Is the Device Single Use?

Yes

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Disability; Other; Required Intervention;

Patient Age

48 YR

Patient Sex

Female

Patient Weight

86 KG

Patient Ethnicity

Non Hispanic

Patient Race

White

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

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