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

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

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Model Number M0068504110

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Fatigue (1849); Micturition Urgency (1871); Pyrosis/Heartburn (1883); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Urinary Retention (2119); Urinary Frequency (2275); Discomfort (2330); Depression (2361); Numbness (2415); Prolapse (2475); Dysuria (2684); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Urinary Incontinence (4572); Swelling/ Edema (4577)

Event Date 09/02/2016

Event Type Injury

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2016, implant procedure date, as no event date was reported.Initial reporter name and address: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6) medical center (b)(6) united states.The explanting surgeon is: dr.(b)(6).(b)(6) united states, (b)(6).(b)(4).The complainant indicated that the device is not available for return; therefore, analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - curved device was implanted into the patient during a mid-urethral sling and cystoscopy procedure performed on (b)(6) 2016 for the treatment of stress urinary incontinence.At the end of the cystoscopy, there was no sign of a tumor, carcinoma in situ, stones, or foreign bodies in the bladder.The ureteral orifices were in their usual anatomic location, and clear urine was effluxing bilaterally.The urethra was normal.There were no complications.The procedure was well tolerated by the patient, and she was brought to the recovery room in stable condition.The patient also underwent a hemorrhoidectomy at the same time.On (b)(6) 2017, the patient states that she was diagnosed with rectal prolapse in 2015 but forgot about it because she underwent rectocele repair in (b)(6) 2015, however she mistook the rectal prolapse for the rectocele surgery and thought it was gone.The patient also had a posterior repair with anal sphincteroplasty in 2004 and reports no stool leakage before or after the surgery.In 2008, she had a supracervical hysterectomy for fibroids, and in 2015, she had a robotic sacrocolpopexy for prolapse.She had a transobturator sling placed for incontinence in (b)(6) 2016, but she still has incontinence and significant groin discomfort.A hemorrhoidectomy was also performed on the patient.In her recovery, she still experiences pain before, during, and after bowel movements, as well as daily bloating, and she feels a lot of pressure on her pelvic floor.She went to see a doctor for an evaluation of her ongoing symptoms following her most recent operation, and part of the evaluation included a pelvic floor magnetic resonance imaging, which revealed moderate to severe rectal prolapse.Furthermore, the patient reports having stools daily, sometimes twice a day (she feels a lot of pain in her bottom, "like a stick up there"), and having stool residue an hour after her bm.She believes that her frequent bowel movements cause anal fissures.She never loses control of her stool while using the restroom, has normal desires, but suffers from severe back pain.She experiences some soiling where she notices stool when she wipes the next time she uses the toilet, but she does not need to use pads as a result.There were no agents to aid her in emptying her stools.The patient hasn't gone to the bathroom every day since 10 days ago, and it feels like an incomplete emptying, which is bothersome and associated with abdominal bloating.Using toilet takes 5-10 minutes.Reportedly, the patient does not feel a rectum bulge coming out, but she does sense a vaginal rectocele bulge returning.She does have low back pain, which she attributes to the insufficient emptying.She experienced similar back pain following her robotic sacrocolpopexy in 2015.She had a colonoscopy before her robotic sacrocolpoexy, which was normal.She is menopausal and receives estrogen replacement prescription most days of the week.An imaging was performed on (b)(6) 2017 which revealed that the patient is consistent with pelvic floor laxity, including descent of the anorectal junction of up to 6.2cm below the pubococcygeal line indicative of moderate to severe rectal prolapse.Reportedly, the patient has pelvic floor dysfunction with high tone pelvic floor and pain related to recent sling surgery, she has daily bowel movements but feels incomplete stool emptying, bloating.She has no symptoms of a bulge coming through the rectum/anus and we see no external anal prolapse.Magnetic resonance imaging suggests some rectal prolapse but she has no fecal incontinence or severe constipation.The patient is gradually worsening.On (b)(6) 2017, the following symptoms were present during the patient's clinic visit: myalgia of pelvic floor, pelvic pain, complication of other implanted genitourinary mesh and unspecified complication.The patient was last seen by the doctor on (b)(6) 2017, for a follow-up on pelvic pain.According to reports, the patient afterwards had groin pain and was prescribed vaginal valium suppositories as well as physical therapy.The patient has a known history of prolapse as detected by dynamic pelvic magnetic resonance imaging and consulted with two doctors, both of whom agreed that the rectal prolapse was not significant and that there was nothing to be done at this time.She is also working on constipation with them with the use of magnesium.According to the patient, she felt like everything was pulling down on her; she had difficulty taking deep breaths; she felt open down there; she felt like it was raw down there; she had discomfort with the rectocele during intercourse; and she had bloating.She believed that the majority of her issues came after the transobturator was implanted.Many of her problems occur while she is attempting to engage in activities such as yoga and exercise.The patient also tried three different drugs for urge incontinence that were not helpful.She still has some incontinence issues.She was found to have high tone pelvic floor muscles during her evaluation, and she was advised to get nerve blocks and botox trigger point injections.She did not follow up on this, therefore she is presenting it in the clinic for re-evaluation and discussion.Exam revealed high tone pelvic floor muscles right>left; pressure on levators reproduces some of the discomfort she feels with intercourse; no mesh exposure, no pain along the path of the sling or in the groin currently.Recommended pudendal nerve block and trigger point injections (botox) into the pelvic floor before considering mesh removal.On (b)(6) 2018, the patient was seen for an evaluation of possible sling complications and consult for mesh removal.The patient had several complaints, including hamstring tightness, "stomach swelling," bloating, pressure from hip to hip, "difficult breathing" (that preceded the sling).She reported dyspnea with exertion for which she had seen her internist.She also reported back pain and a feeling that everything is "pushing down." she also reported increased fatigue as well as decreased range of motion during yoga - all of which the patient attributed to the sling.Her internist had apparently ruled out lyme/mono and other sources of fatigue and dyspnea.She also reported that since she had the sling, she had not been able to achieve orgasms.She also reported feeling a bulge and thought her rectocele was back.She also reported pressure when she gets up and she has a sense of pressure/urgency.Some mild sui persisted.The patient also experienced pain with sex (entrance and deep dyspareunia).The patient had attended pfpt (pelvic floor physical therapy) for 15 sessions and tried vaginal valium for her symptoms.Physical therapy helped a bit, but valium was not helpful.She has also tried mirabegron (she did not tolerate), ditropan x 1 month without improvement (she also noted dryness).No bladder testing repeated after sling.She had a feeling of incomplete emptying and felt the need to double void.Her previous dynamics mri was essentially normal - without anismus or rectal intussuception.The patient was also experiencing hot flashes, which led to her drinking large volumes of water.Assessment/plan 1.Pelvic pressure in female the physician explained to the patient that she had no prolapse, and no evidence of voiding dysfunction.Her symptoms are vague and the physician explained that they may not be related to her transobturator sling.She has tenderness of the pelvic floor muscles, but she has completed pt.Given the concomitant bloating, it may be reasonable for her to seek gi input to r/o ibs or diverticulosis/itis.2.Mixed incontinence no leaks on pelvic exam.She was drinking large amounts of water, which was likely aggravating her symptoms.Urodynamics/cysto to be repeated given that she also reported sometimes seeing "tissue" in her urine.The physician suspected that she may have detrusor overactivity (do), and she has previously tried 2 oab medications.If testing confirms do, could consider ptns or botox.However, her main complaint at that point seemed to be her pressure and the sensation that everything is "falling." 3.Female dyspareunia likely partially related to levator spasm.While she is tender at the r puborectalis, the sling itself is not tender and she denies medial thigh pain.4.Bloating see #1 5.Fecal smearing see #1 6.Nocturia behavioral modifications were reviewed in detail including caffeine elimination, timed voids, and fluid restriction.Worksheet given.7.Menopausal hot flushes the physician advised she discuss this further with her primary gyn as she is consuming large amounts of water for her symptoms.She reports a family history of breast cancer and does not seem interested in local estrogen.The patient had varied symptoms, and the physician believed most were unlikely to be related to the obtryx sling.Further abdominal imaging could be obtained, but the physician thought the likelihood of an ongoing intra-abdominal process was low.Could consider ct with contrast (incl oral) as that could evaluate for diverticular disease and also could possibly see the sacrum (she has back pain but discitis seems unlikely).In the absence of meaningful findings, the phyician continued to discourage sling removal since her symptoms are varied and vague and are not likely to be relieved by sling removal.The physician did explain that a likely outcome of sling removal would be increased incontinence but persistent fatigue/bloating/pressure/dyspareunia/hamstring tightness.Finally, the physician heard wheezing on her lung exam and the patient complained of dyspnea.The physician suggested reevaluation with her pmd or pulmonology (although sp02 normal).On (b)(6) 2018, the patient underwent bilateral pudendal nerve block, trigger point injections into the pelvic floor using botox 100 units due to groin pain and on exam with high tone pelvic floor dysfunction.Operative findings were: normal external female genitalia; adequate support of all vaginal compartments without evidence of prolapse; no evidence of mesh exposure; high tone pelvic floor muscles, right greater than left.During the procedure, after anesthesia was administered, the patient was placed in high dorsal lithotomy position with careful attention paid to leg positioning to ensure there was no hyperextension or hyperflexion of her joints to avoid muscular or neurological damage.Exam-under anesthesia was performed with the findings as noted above.The patient's vagina, perineum, and suprapubic area were prepped and draped in the usual sterile fashion.A surgical time-out was completed in which the patient as well as the procedure was identified and confirmed.They then proceeded with bilateral pudendal nerve blocks.They identified the location of the pudendal nerves bilaterally by palpating the ischial spine and the sacrospinous ligament, using the iowa trumpet to inject 10 ml of the 20 ml solution of 0.5% bupivicaine mixed with 40 mg kenalog 1 cm medial and posterior to the ischial spine on the right side.The same procedure was repeated on the left side injecting the remaining 10 ml of the 20 ml solution of 0.5% bupivicaine mixed with 40 mg kenalog.Next they proceeded with the trigger point injections.100 units of botox was mixed into 10 ml of injectable saline.They palpated tight areas of muscles throughout the levator ani muscles and the obturator internus muscles bilaterally.They injected 3 sites on the right and 2 sites on the left and distributed the 100 unites of botox among these 5 sites using using the iowa trumpet.All instruments were removed from the vagina.The vagina was hemostatic.Counts were correct x2.The patient was taken out of dorsal lithotomy position.The patient tolerated the procedure well.There were no complications.On (b)(6) 2018, the patient states that things have improved slightly following her nerve blocks and botox injections on (b)(6) 2018.She can now do and/or hold various yoga practices that she couldn't before.She is still experiencing pressure and groin pulling.She caught the flu after the botox, which hindered her recovery and made it difficult for her to tell how she was doing at first.She attempted intercourse and had pain upon entering, but things improved after that.Exam revealed high tone pelvic floor muscles right>left but less than prior to botox.The diagnoses were pelvic pain, myalgia or pelvic floor, and muscle spasm.The plan was for the patient to use lidocaine gel prior to intercourse, repeat injections in the future, and keep consult with urogynecologist.On (b)(6) 2018, the patient reports the following problems during her visit: mesh problems - the symptoms are reported as being severe.The symptoms occur daily.The location is vagina, aggravating factors include exiting car.Relieving factors include motrin, tylenol.She states the symptoms are chronic and are uncontrolled.Patient presents with complaints of mesh problems.Her main pain symptoms are related to groin pain and the right side is worse than the left.She reports pain with exiting the car as a passenger and a driver.She also reports pain at the top of her vagina.She underwent botox in march for pelvic floor dysfunction.She reports complaints or urinary leakage with laugh/cough/sneeze.She reports leakage with urgency as well.She does report a bulge at the entrance to the vagina and believes her rectocele has returned.She reports occasional fecal incontinence x2 episodes in the last year.She denies constipation.She is sexually active and reports with pain with intercourse.She reports dyspareunia which is worse over the last 3 weeks.Review of systems included the following relevant symptoms: dysuria, incomplete emptying, nocturia x 1, urge incontinence, urgency, urinary frequency, depression.Exam revealed pain at the left and right obturator internus muscles, cords lateral to bladder neck.The patient was offered removal of the obtryx sling, paravaginal dissection, urethral lysis, anterior colporrhaphy, and removal of the mesh from the obturators and adductors.On (b)(6) 2018, the patient was seen for a fifth opinion for mesh removal.Since the obtryx trans-obturator tape in (b)(6) 2016 the patient feels pain.She has pain in the hips.She feels that her bladder is cut in half and she feels bloating in the abdominal cavity and swelling in the inner thighs.She had seen several specialists at that point.She had seen a physician in (b)(6) 2018 requesting sling removal but wanted another opinion.She saw another physician who felt the mesh was not causing the pain issues and offered conservative treatment.Then she saw yet another physician, and the patient reported that physician felt the mesh was too high and too tight.The patient wants the mesh removed.Since receiving the mesh sling, the patient felt she had had significant symptoms and complications.Sexual symptoms included pain with insertion and even pain with fingering.Her pain was less with deep penetration.She could not orgasm anymore and feels numb and feels g spot no longer exists.Her clitoris was not as sensitive as it used to be, loss sensation even with masturbation.No coital loss of urine.Urinary symptoms include frequent voiding; she does not leak at gym because she voids frequently and sweats during body jam class; wearing pads 3 per day always #2 pads; does not feel she is emptying ok and has to sit for 10 mins and void three times to empty; no utls and no hematuria.Post void residual was 150 ml as measured by straight catheterization.Bowel symptoms: bms at least 4 per week; feels rectocele is impacting.Last colonoscopy age 49 wnl.She reported that the recent levator botox injection on (b)(6) 2018 did not alleviate her symptoms.Review of systems was positive for fever, weight gain, chest pain, sob, nausea, abdominal pain, gerd, back pain, joint pain, skin rash, brsing, anemia, hayfever side stitch or something or a certain yoga position will cause her not to be able to catch her breath--short lived and feels everything is being dragged and mal-aligned due to the sling.The patient desired sling mesh removal with bilateral groin dissection.The physician wanted to review urodynamics and schedule cystoscopy and preop discussion.On (b)(6) 2018, the patient had an office visit for a preop discussion.The patient is s/p obtryx ii transobturator tape on (b)(6) 2016 and also s/p (b)(6) 2015 robotic sacrocolpopexy, posterior repair, urethrolysis, right salpingo-oophorectomy, excision of endometriosis implants.Cystoscopy performed on (b)(6) 2018 showed no mesh erosion.The patient reported that prior to sling surgery in (b)(6) 2016, she had a groin pain and felt she pulled a muscle.She was told she would get the retropubic sling avoiding the groin.The day of surgery, the patient reports the plan changed and she received the transobturator sling instead.(patient signed consent for transobturator) since the operative, patient has had significant dyspareunia and bladder pain.Patient reported she feels as if she is being "strangled at the pubic bone" and pain that is in a belt like distribution from hip to hip.Patient reports at times the pain causes her to not be able to breathe.Patient feels pain at the vaginal incision site.Feels pain at the top of her vagina.Due to the pain, the patient previously saw another healthcare provider, but did not get mesh removed.The patient reported she was leaking worse than she did prior to surgery.Patient wears pads every day.Assessment/plan 1.Complication of implanted vaginal mesh t85.9xxa dyspareunia, bladder pain s/p obtryx ii transobturator sling placement in (b)(6) 2016; cystoscopy showed no mesh erosion on (b)(6) 2018) patient counseled that the healthcare provider would remove the mesh transvaginally and through the groin; patient and partner asked appropriate questions regarding procedure; patient told that 1-2% of patients have complications from the mesh; small percentage of people who when they take out the mesh the scar tissue prevents leakage but there is a possibility she would have recurrent stress incontinence and also persistent pain after the surgery 2.Female dyspareunia n94.10 see #1 obtryx ii removal surgery, tentative date: on (b)(6) 2018; holding the date for now will f/u with pre-op (after (b)(6) 2018) risks- incomplete removal, persistent pain, potential to leak again.Attending physician's impressions: 30 mins spent with patient and husband; will consider options and return for final preop.On (b)(6) 2019, the patient underwent an intraoperative ultrasound guidance, removal of vaginal sling, anterior repair, laparoscopic ureterolysis and enterolysis.During the intraoperative ultrasound guidance, the used a bk3000 ultrasound machine and localized the sling location and extent.It was noted that on the right side, there were some hyperechoic areas and density close to the ischiopubic rami where the patient had pain.This area was tucked.During the surgery, the distal margin of the suburethral region was incised.With 10 ml of marcaine, this was hydrodissected.The vaginal epithelium was cephalad expanded and sliced in the midline.The underlying tissue was separated from the vaginal epithelium.They carefully dissected upward.The blue-colored sling was in the deeper layers, and it appeared to be roiled under anesthesia.This was undermined, and the sling was localized in the midline, grabbed with two kocher clamps, and separated in the center, providing quick relief.Lateral dissection was performed to the margins of the ischiopubic rami.The sling was strongly adherent to the right ischiopubic rami on the right side and they freed it and were able to release it from the obturator fossa by tugging cephalad.The sling on the left side was going more cephalad and not straight into the obturator fossa, but rather into the levator, and this was also removed completely.Anterior repair was performed by plicating pubourethral ligaments tied %2 using 2-0 pds sutures under the urethra to provide support to hopefully prevent patient's subsequent stress urinary incontinence.The vaginal epithelium was a slightly trimmed and closed in the midline using 2-0 vicryl in running fashion.They performed a laparoscopy and noticed that the distance between the pubic bone and the umbilicus was narrow, hence they chose a supraumbilical route given the nature of the patient's pain.Marcaine (5 ml) was then injected into to the affected area.After inserting a veress needle in this location, the abdomen was insufflated with 3 liters of normal saline.In a neurovascularly safe manner, a 5-mm trocar was placed.A scan of the pelvic cavity revealed the sacrocolpopexy mesh, with a small bowel loop adhering to the center of it.A 5-mm trocar was inserted in the right lower quadrant, an 11-mm in the left lower quadrant, and another 5 mm in the left lower quadrant medial to the inferior epigastric vessels.The dissection was done to free up the small bowel and open a peritoneal window for ureterolysis while keeping the right ureter protected from the area of dissection.After opening the peritoneal window, they noticed that the ureter was at a safe distance on the right side.The colon was meticulously dissected, and the adherent area of the bowel to the mesh, which was a thick scar band, was located, coagulated, and subdivided using the ligasure device.Further dissection was performed to free up the bowel from the mesh region.To avoid future adhesion, they placed a seprafilm over the dissection site.The 11-mm trocar site was closed with 0 vicryl utilizing a carter-thomason device.The skin was closed subcuticularly with 4-0 monocryl.Dermabond adhesive was used.A cystoscopy was conducted, which demonstrated good urine outflow from both sides.The procedure was well tolerated by the patient.The patient's condition was reviewed with the patient's husband, who was pleased.The rest of the peritoneal cavity exhibited normal anatomy as well.On (b)(6) 2019, the patient was seen for swelling and inflammation at the area of her mesh removal and painful bowel movements.On (b)(6) 2020, the patient had cystometrogram which showed no sui with cough, sitting, or standing; no leaking with valsalva; urgency with sensation of water, no leaking; and no retention.On (b)(6) 2020, the patient presents to the clinic for referral request for echocardiogram and she is also requesting to see a urogynecologist who performs mesh removal.Reportedly, the patient still has some pelvic and sacral pain despite previous surgery in addition to occasional dysuria, urgency, and incontinence.The patient was referred to a urogynecologist.On (b)(6) 2020, the patient complains of having her rectum squeezed and her bowels being quite noisy in the morning.She does state that when she moves her bowels, she experiences sharp pains, and her bowel movements are still episodic, with days when she needs to take miralax or another type of stool softener to assist herself pass.She underwent a colonoscopy a year ago, and everything appeared to be fine.Basically, she's here for a follow-up.She is staying healthy by exercising physically and doing pelvic floor exercises 2-3 times a week.Overall, the doctor believes the patient is doing well.Her pelvic floor physical therapy has been quite beneficial to her.Her pain has subsided.She still has some bowel difficulties, which the doctor believes would improve with more consistent usage of bowel medications, such as miralax.This could also assist with her rectal discomfort.The doctor suggested that she consider repeating a magnetic resonance imaging merely to reevaluate the pelvic floor and determine where she is in terms of recurring prolapse, and then to continue with physical therapy, avoid straining, and follow-up with the doctor.The patient referred herself to the clinic for nerve damage and pain on (b)(6) 2022.The patient claims that after the transobturator tape was partially removed, she experienced pain, numbness, and nerve damage from the lower abdomen to the clitoris.She also claims that sitting for 30 minutes or more would hurt her back.She reported spontaneous vulvar pain without touch that is intermittent, entry and deep dyspareunia, postcoital pain described as burning irritation for 10 minutes, bilateral inner thigh pain that goes down to her feet and voiding every 2 hours.Exam revealed erythema around gland openings, q-tip tenderness to vestibule, atrophy, no spasm or pelvic floor tenderness, left leg longer than right, mild tenderness with obturator nerve palpation, and pain reproduction with palpation of left pudendal nerve.The assessment included post-mesh vulvar and pelvic pain for which the patient was to increase premarin use; pelvic floor tenderness without spasm possibly due to leg length inequality; mild pudendal neuropathy and possible obturator neuropathy; chronic interstitial cystitis.The patient sought treatment for pudendal neuralgia on (b)(6) 2022.Her present symptoms are suprapubic pressure "like a belt from hip to hip," according to the patient.It improves if she lies down and places a heating pad on it.When she sits up, she feels worse, and when she reclines, she feels slightly better.She can feel something round and hard near her past hysterectomy incision while she's standing, but the pain is more dispersed.Eating, drinking, urinating, or defecating have no impact.There is no relief from voiding.The left side is marginally worse.It hasn't gotten any better in the last two years, and ditropan isn't making things better.This is a challenging condition for this patient, who has long suffered from pelvic pain and pressure, as well as a variety of other symptoms, according to the doctor.It's unclear whether her symptoms have improved or worsened as a result of her previous procedures.She is considering more surgery (removal of the extrapelvic portion of her transobturator mesh.) the likelihood of success with that strategy is difficult to determine.Boston scientific received an additional information on november 11, 2022 as follows: on (b)(6) 2018, the patient called the health care facility and would like to see a surgeon to have her pelvic mesh removed.On (b)(6) 2018, the patient thinks that her pain has now reached the bottom of her feet.The patient has been using aspercreme on her feet and using some heel cushions with slight improvement.The patient has new shoes, but they have not resolved the pain.Moreover, the patient is working with specialists to have her pelvic mesh removed as swelling in the lateral epicondylalgia and abdominal region has been constant and increases when she does her knee exercises.Furthermore, the patient had plantar fascial fibromatosis.Reportedly, her symptoms are due to kinematic challenges starting in the pelvis and going down through the knees and feet.She was in the home program and management.Additionally, the patient presented the following problems: presbyopia low back pain pain in unspecified knee unspecified urinary incontinence pain in right shoulder gastroesophageal reflux disease without esophagitis osteopenia breast fibrocystic disease on (b)(6) 2019, the patient complains of swelling in her right breast and does not know how long it has been there.She states that she has had ongoing blood pressure fluctuations since the procedure for her mesh removal.Her blood pressure readings have varied, from systolic up to 150.Reportedly, the patient is back to doing yoga again.Her pressure is in the epigastrium; there is no reflux or nausea.On (b)(6) 2020, the patient comes at the clinic with a cardiologist referral request for an echocardiography.The patient also wants to consult a urogynecologist who can remove mesh.According to reports, the patient had two mesh slings inserted for bladder incontinence, which were causing severe gastrointestinal issues.She also had some mesh removed by a surgeon in virginia, but not all of it.Despite the previous surgery, she still has some pelvic and sacral pain.The patient thinks she has facet arthritis in addition to normal osteoarthritis as of (b)(6) 2020.She had various problems with her urethral sling in 2016, which affected her back.According to reports, the left half of the mesh was removed because it was excessively tight and pulled forward.The patient believes she cannot walk regularly or comfortably.She has been doing yoga and pilates to cope with the pain and will continue to do so.The patient also stated that being more active made her feel better.Objective/examination: posture sitting: frequent moving.Demonstrates she feels most comfortable sitting equal and supported.Standing: unremarkable gait: within normal limits, slight forward lean and feel of pelvis pulling in intermittently.Functional activity: air squat: femurs to parallel, feels like her back is being pulled in and down.The patient tolerated treatment well.Prognosis: good with continued physical therapy treatment and adherence to home exercise program.Diagnosis: low back pain functional limitations include: reduced core strength, specifically in rotational and side strength.Sensation of internal tightness in pelvis.Will benefit from home exercise program and graded return to more activity to improve comfortably with movement.

Manufacturer Narrative

Block h2: additional information blocks b5 (narrative) and h6 (patient codes) has been updated based on the additional information received on november 11, 2022.Block b3 date of event: date of event was approximated to september 2, 2016, implant procedure 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) dr.(b)(6) medical center (b)(6).The explanting surgeon is: (b)(6) dr.(b)(6) fairfax.(b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2101 - adhesions e2330 - pain e2320 - dyspareunia e1301 - dysuria e1309 - urinary retention e0123 - nerve damage e2326 - inflammation e0126 - neuropathy e2338 - swelling/edema e020202 - depression the following imdrf impact codes capture the reportable events of: f2303 - required medication f23 - unexpected medical intervention f1905 - device revision or replacement.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - curved device was implanted into the patient during a mid-urethral sling and cystoscopy procedure performed on (b)(6) 2016 for the treatment of stress urinary incontinence.At the end of the cystoscopy, there was no sign of a tumor, carcinoma in situ, stones, or foreign bodies in the bladder.The ureteral orifices were in their usual anatomic location, and clear urine was effluxing bilaterally.The urethra was normal.There were no complications.The procedure was well tolerated by the patient, and she was brought to the recovery room in stable condition.The patient also underwent a hemorrhoidectomy at the same time.On (b)(6) 2017, the patient states that she was diagnosed with rectal prolapse in 2015 but forgot about it because she underwent rectocele repair in (b)(6) 2015, however she mistook the rectal prolapse for the rectocele surgery and thought it was gone.The patient also had a posterior repair with anal sphincteroplasty in 2004 and reports no stool leakage before or after the surgery.In 2008, she had a supracervical hysterectomy for fibroids, and in 2015, she had a robotic sacrocolpopexy for prolapse.She had a transobturator sling placed for incontinence in (b)(6) 2016, but she still has incontinence and significant groin discomfort.A hemorrhoidectomy was also performed on the patient.In her recovery, she still experiences pain before, during, and after bowel movements, as well as daily bloating, and she feels a lot of pressure on her pelvic floor.She went to see a doctor for an evaluation of her ongoing symptoms following her most recent operation, and part of the evaluation included a pelvic floor magnetic resonance imaging, which revealed moderate to severe rectal prolapse.Furthermore, the patient reports having stools daily, sometimes twice a day (she feels a lot of pain in her bottom, "like a stick up there"), and having stool residue an hour after her bm.She believes that her frequent bowel movements cause anal fissures.She never loses control of her stool while using the restroom, has normal desires, but suffers from severe back pain.She experiences some soiling where she notices stool when she wipes the next time she uses the toilet, but she does not need to use pads as a result.There were no agents to aid her in emptying her stools.The patient hasn't gone to the bathroom every day since 10 days ago, and it feels like an incomplete emptying, which is bothersome and associated with abdominal bloating.Using toilet takes 5-10 minutes.Reportedly, the patient does not feel a rectum bulge coming out, but she does sense a vaginal rectocele bulge returning.She does have low back pain, which she attributes to the insufficient emptying.She experienced similar back pain following her robotic sacrocolpopexy in 2015.She had a colonoscopy before her robotic sacrocolpoexy, which was normal.She is menopausal and receives estrogen replacement prescription most days of the week.An imaging was performed on (b)(6) 2017 which revealed that the patient is consistent with pelvic floor laxity, including descent of the anorectal junction of up to 6.2cm below the pubococcygeal line indicative of moderate to severe rectal prolapse.Reportedly, the patient has pelvic floor dysfunction with high tone pelvic floor and pain related to recent sling surgery, she has daily bowel movements but feels incomplete stool emptying, bloating.She has no symptoms of a bulge coming through the rectum/anus and we see no external anal prolapse.Magnetic resonance imaging suggests some rectal prolapse but she has no fecal incontinence or severe constipation.The patient is gradually worsening.On (b)(6) 2017, the following symptoms were present during the patient's clinic visit: myalgia of pelvic floor, pelvic pain, complication of other implanted genitourinary mesh and unspecified complication.The patient was last seen by the doctor on (b)(6) 2017, for a follow-up on pelvic pain.According to reports, the patient afterwards had groin pain and was prescribed vaginal valium suppositories as well as physical therapy.The patient has a known history of prolapse as detected by dynamic pelvic magnetic resonance imaging and consulted with two doctors, both of whom agreed that the rectal prolapse was not significant and that there was nothing to be done at this time.She is also working on constipation with them with the use of magnesium.According to the patient, she felt like everything was pulling down on her; she had difficulty taking deep breaths; she felt open down there; she felt like it was raw down there; she had discomfort with the rectocele during intercourse; and she had bloating.She believed that the majority of her issues came after the transobturator was implanted.Many of her problems occur while she is attempting to engage in activities such as yoga and exercise.The patient also tried three different drugs for urge incontinence that were not helpful.She still has some incontinence issues.She was found to have high tone pelvic floor muscles during her evaluation, and she was advised to get nerve blocks and botox trigger point injections.She did not follow up on this, therefore she is presenting it in the clinic for re-evaluation and discussion.Exam revealed high tone pelvic floor muscles right>left; pressure on levators reproduces some of the discomfort she feels with intercourse; no mesh exposure, no pain along the path of the sling or in the groin currently.Recommended pudendal nerve block and trigger point injections (botox) into the pelvic floor before considering mesh removal.On (b)(6) 2018, the patient was seen for an evaluation of possible sling complications and consult for mesh removal.The patient had several complaints, including hamstring tightness, "stomach swelling," bloating, pressure from hip to hip, "difficult breathing" (that preceded the sling).She reported dyspnea with exertion for which she had seen her internist.She also reported back pain and a feeling that everything is "pushing down." she also reported increased fatigue as well as decreased range of motion during yoga - all of which the patient attributed to the sling.Her internist had apparently ruled out lyme/mono and other sources of fatigue and dyspnea.She also reported that since she had the sling, she had not been able to achieve orgasms.She also reported feeling a bulge and thought her rectocele was back.She also reported pressure when she gets up and she has a sense of pressure/urgency.Some mild sui persisted.The patient also experienced pain with sex (entrance and deep dyspareunia).The patient had attended pfpt (pelvic floor physical therapy) for 15 sessions and tried vaginal valium for her symptoms.Physical therapy helped a bit, but valium was not helpful.She has also tried mirabegron (she did not tolerate), ditropan x 1 month without improvement (she also noted dryness).No bladder testing repeated after sling.She had a feeling of incomplete emptying and felt the need to double void.Her previous dynamics mri was essentially normal - without anismus or rectal intussuception.The patient was also experiencing hot flashes, which led to her drinking large volumes of water.Assessment/plan: 1.Pelvic pressure in female the physician explained to the patient that she had no prolapse, and no evidence of voiding dysfunction.Her symptoms are vague and the physician explained that they may not be related to her transobturator sling.She has tenderness of the pelvic floor muscles, but she has completed pt.Given the concomitant bloating, it may be reasonable for her to seek gi input to r/o ibs or diverticulosis/itis.2.Mixed incontinence: no leaks on pelvic exam.She was drinking large amounts of water, which was likely aggravating her symptoms.Urodynamics/cysto to be repeated given that she also reported sometimes seeing "tissue" in her urine.The physician suspected that she may have detrusor overactivity (do), and she has previously tried 2 oab medications.If testing confirms do, could consider ptns or botox.However, her main complaint at that point seemed to be her pressure and the sensation that everything is "falling." 3.Female dyspareunia: likely partially related to levator spasm.While she is tender at the r puborectalis, the sling itself is not tender and she denies medial thigh pain.4.Bloating: see #1.5.Fecal smearing: see #1.6.Nocturia: behavioral modifications were reviewed in detail including caffeine elimination, timed voids, and fluid restriction.Worksheet given.7.Menopausal hot flushes the physician advised she discuss this further with her primary gyn as she is consuming large amounts of water for her symptoms.She reports a family history of breast cancer and does not seem interested in local estrogen.The patient had varied symptoms, and the physician believed most were unlikely to be related to the obtryx sling.Further abdominal imaging could be obtained, but the physician thought the likelihood of an ongoing intra-abdominal process was low.Could consider ct with contrast (incl oral) as that could evaluate for diverticular disease and also could possibly see the sacrum (she has back pain but discitis seems unlikely).In the absence of meaningful findings, the physician continued to discourage sling removal since her symptoms are varied and vague and are not likely to be relieved by sling removal.The physician did explain that a likely outcome of sling removal would be increased incontinence but persistent fatigue/bloating/pressure/dyspareunia/hamstring tightness.Finally, the physician heard wheezing on her lung exam and the patient complained of dyspnea.The physician suggested reevaluation with her pmd or pulmonology (although sp02 normal).On (b)(6) 2018, the patient underwent bilateral pudendal nerve block, trigger point injections into the pelvic floor using botox 100 units due to groin pain and on exam with high tone pelvic floor dysfunction.Operative findings were: normal external female genitalia; adequate support of all vaginal compartments without evidence of prolapse; no evidence of mesh exposure; high tone pelvic floor muscles, right greater than left.During the procedure, after anesthesia was administered, the patient was placed in high dorsal lithotomy position with careful attention paid to leg positioning to ensure there was no hyperextension or hyperflexion of her joints to avoid muscular or neurological damage.Exam-under anesthesia was performed with the findings as noted above.The patient's vagina, perineum, and suprapubic area were prepped and draped in the usual sterile fashion.A surgical time-out was completed in which the patient as well as the procedure was identified and confirmed.They then proceeded with bilateral pudendal nerve blocks.They identified the location of the pudendal nerves bilaterally by palpating the ischial spine and the sacrospinous ligament, using the iowa trumpet to inject 10 ml of the 20 ml solution of 0.5% bupivicaine mixed with 40 mg kenalog 1 cm medial and posterior to the ischial spine on the right side.The same procedure was repeated on the left side injecting the remaining 10 ml of the 20 ml solution of 0.5% bupivicaine mixed with 40 mg kenalog.Next they proceeded with the trigger point injections.100 units of botox was mixed into 10 ml of injectable saline.They palpated tight areas of muscles throughout the levator ani muscles and the obturator internus muscles bilaterally.They injected 3 sites on the right and 2 sites on the left and distributed the 100 unites of botox among these 5 sites using the iowa trumpet.All instruments were removed from the vagina.The vagina was hemostatic.Counts were correct x2.The patient was taken out of dorsal lithotomy position.The patient tolerated the procedure well.There were no complications.On (b)(6) 2018, the patient states that things have improved slightly following her nerve blocks and botox injections on (b)(6) 2018.She can now do and/or hold various yoga practices that she couldn't before.She is still experiencing pressure and groin pulling.She caught the flu after the botox, which hindered her recovery and made it difficult for her to tell how she was doing at first.She attempted intercourse and had pain upon entering, but things improved after that.Exam revealed high tone pelvic floor muscles right>left but less than prior to botox.The diagnoses were pelvic pain, myalgia or pelvic floor, and muscle spasm.The plan was for the patient to use lidocaine gel prior to intercourse, repeat injections in the future, and keep consult with urogynecologist.On (b)(6) 2018, the patient reports the following problems during her visit: mesh problems - the symptoms are reported as being severe.The symptoms occur daily.The location is vagina, aggravating factors include exiting car.Relieving factors include motrin, tylenol.She states the symptoms are chronic and are uncontrolled.Patient presents with complaints of mesh problems.Her main pain symptoms are related to groin pain and the right side is worse than the left.She reports pain with exiting the car as a passenger and a driver.She also reports pain at the top of her vagina.She underwent botox in march for pelvic floor dysfunction.She reports complaints or urinary leakage with laugh/cough/sneeze.She reports leakage with urgency as well.She does report a bulge at the entrance to the vagina and believes her rectocele has returned.She reports occasional fecal incontinence x2 episodes in the last year.She denies constipation.She is sexually active and reports with pain with intercourse.She reports dyspareunia which is worse over the last 3 weeks.Review of systems included the following relevant symptoms: dysuria, incomplete emptying, nocturia x 1, urge incontinence, urgency, urinary frequency, depression.Exam revealed pain at the left and right obturator internus muscles, cords lateral to bladder neck.The patient was offered removal of the obtryx sling, paravaginal dissection, urethral lysis, anterior colporrhaphy, and removal of the mesh from the obturators and adductors.On (b)(6) 2018, the patient was seen for a fifth opinion for mesh removal.Since the obtryx trans-obturator tape in (b)(6) 2016 the patient feels pain.She has pain in the hips.She feels that her bladder is cut in half and she feels bloating in the abdominal cavity and swelling in the inner thighs.She had seen several specialists at that point.She had seen a physician in (b)(6) 2018 requesting sling removal but wanted another opinion.She saw another physician who felt the mesh was not causing the pain issues and offered conservative treatment.Then she saw yet another physician, and the patient reported that physician felt the mesh was too high and too tight.The patient wants the mesh removed.Since receiving the mesh sling, the patient felt she had significant symptoms and complications.Sexual symptoms included pain with insertion and even pain with fingering.Her pain was less with deep penetration.She could not orgasm anymore and feels numb and feels g spot no longer exists.Her clitoris was not as sensitive as it used to be, loss sensation even with masturbation.No coital loss of urine.Urinary symptoms include frequent voiding; she does not leak at gym because she voids frequently and sweats during body jam class; wearing pads 3 per day always #2 pads; does not feel she is emptying ok and has to sit for 10 mins and void three times to empty; no utls and no hematuria.Post void residual was 150 ml as measured by straight catheterization.Bowel symptoms: bms at least 4 per week; feels rectocele is impacting.Last colonoscopy age 49 wnl.She reported that the recent levator botox injection (b)(6) 2018 did not alleviate her symptoms.Review of systems was positive for fever, weight gain, chest pain, sob, nausea, abdominal pain, gerd, back pain, joint pain, skin rash, brsing, anemia, hayfever side stitch or something or a certain yoga position will cause her not to be able to catch her breath--short lived and feels everything is being dragged and mal-aligned due to the sling the patient desired sling mesh removal with bilateral groin dissection.The physician wanted to review urodynamics and schedule cystoscopy and preop discussion.On (b)(6)2018, the patient had an office visit for a preop discussion.The patient is s/p obtryx ii transobturator tape (b)(6) 2016 and also s/p (b)(6) 2015 robotic sacrocolpopexy, posterior repair, urethrolysis, right salpingo-oophorectomy, excision of endometriosis implants.Cystoscopy performed (b)(6) 2018 showed no mesh erosion.The patient reported that prior to sling surgery in (b)(6) 2016, she had a groin pain and felt she pulled a muscle.She was told she would get the retropubic sling avoiding the groin.The day of surgery, the patient reports the plan changed and she received the transobturator sling instead.(patient signed consent for transobturator) since the operative, patient has had significant dyspareunia and bladder pain.Patient reported she feels as if she is being "strangled at the pubic bone" and pain that is in a belt like distribution from hip to hip.Patient reports at times the pain causes her to not be able to breathe.Patient feels pain at the vaginal incision site.Feels pain at the top of her vagina.Due to the pain, the patient previously saw another healthcare provider, but did not get mesh removed.The patient reported she was leaking worse than she did prior to surgery.Patient wears pads everyday.Assessment/plan 1.Complication of implanted vaginal mesh t85.9xxa dyspareunia, bladder pain s/p obtryx ii transobturator sling placement in (b)(6) 2016; cystoscopy showed no mesh erosion ((b)(6) 2018) patient counseled that the healthcare provider would remove the mesh transvaginally and through the groin; patient and partner asked appropriate questions regarding procedure; patient told that 1-2% of patients have complications from the mesh; small percentage of people who when they take out the mesh the scar tissue prevents leakage but there is a possibility she would have recurrent stress incontinence and also persistent pain after the surgery 2.Female dyspareunia n94.10: see #1.Obtryx ii removal surgery, tentative date: (b)(6) 2018; holding the date for now will f/u with pre-op (after (b)(6) 2018) risks- incomplete removal, persistent pain, potential to leak again.Attending physician's impressions: 30 mins spent with patient and husband; will consider options and return for final preop.On (b)(6) 2019, the patient underwent an intraoperative ultrasound guidance, removal of vaginal sling, anterior repair, laparoscopic ureterolysis and enterolysis.During the intraoperative ultrasound guidance, the used a bk3000 ultrasound machine and localized the sling location and extent.It was noted that on the right side, there were some hyperechoic areas and density close to the ischiopubic rami where the patient had pain.This area was tucked.During the surgery, the distal margin of the suburethral region was incised.With 10 ml of marcaine, this was hydrodissected.The vaginal epithelium was cephalad expanded and sliced in the midline.The underlying tissue was separated from the vaginal epithelium.They carefully dissected upward.The blue-colored sling was in the deeper layers, and it appeared to be roiled under anesthesia.This was undermined, and the sling was localized in the midline, grabbed with two kocher clamps, and separated in the center, providing quick relief.Lateral dissection was performed to the margins of the ischiopubic rami.The sling was strongly adherent to the right ischiopubic rami on the right side and they freed it and were able to release it from the obturator fossa by tugging cephalad.The sling on the left side was going more cephalad and not straight into the obturator fossa, but rather into the levator, and this was also removed completely.Anterior repair was performed by plicating pubourethral ligaments tied %2 using 2-0 pds sutures under the urethra to provide support to hopefully prevent patient's subsequent stress urinary incontinence.The vaginal epithelium was a slightly trimmed and closed in the midline using 2-0 vicryl in running fashion.They performed a laparoscopy and noticed that the distance between the pubic bone and the umbilicus was narrow, hence they chose a supraumbilical route given the nature of the patient's pain.Marcaine (5 ml) was then injected into to the affected area.After inserting a veress needle in this location, the abdomen was insufflated with 3 liters of normal saline.In a neurovascularly safe manner, a 5-mm trocar was placed.A scan of the pelvic cavity revealed the sacrocolpopexy mesh, with a small bowel loop adhering to the center of it.A 5-mm trocar was inserted in the right lower quadrant, an 11-mm in the left lower quadrant, and another 5 mm in the left lower quadrant medial to the inferior epigastric vessels.The dissection was done to free up the small bowel and open a peritoneal window for ureterolysis while keeping the right ureter protected from the area of dissection.After opening the peritoneal window, they noticed that the ureter was at a safe distance on the right side.The colon was meticulously dissected, and the adherent area of the bowel to the mesh, which was a thick scar band, was located, coagulated, and subdivided using the ligasure device.Further dissection was performed to free up the bowel from the mesh region.To avoid future adhesion, they placed a seprafilm over the dissection site.The 11-mm trocar site was closed with 0 vicryl utilizing a carter-thomason device.The skin was closed subcuticularly with 4-0 monocryl.Dermabond adhesive was used.A cystoscopy was conducted, which demonstrated good urine outflow from both sides.The procedure was well tolerated by the patient.The patient's condition was reviewed with the patient's husband, who was pleased.The rest of the peritoneal cavity exhibited normal anatomy as well.On (b)(6) 2019, the patient was seen for swelling and inflammation at the area of her mesh removal and painful bowel movements.On (b)(6) 2020, the patient had cystometrogram which showed no sui with cough, sitting, or standing; no leaking with valsalva; urgency with sensation of water, no leaking; and no retention.On (b)(6) 2020, the patient presents to the clinic for referral request for echocardiogram and she is also requesting to see a urogynecologist who performs mesh removal.Reportedly, the patient still has some pelvic and sacral pain despite previous surgery in addition to occasional dysuria, urgency, and incontinence.The patient was referred to a urogynecologist.On (b)(6) 2020, the patient complains of having her rectum squeezed and her bowels being quite noisy in the morning.She does state that when she moves her bowels, she experiences sharp pains, and her bowel movements are still episodic, with days when she needs to take miralax or another type of stool softener to assist herself pass.She underwent a colonoscopy a year ago, and everything appeared to be fine.Basically, she's here for a follow-up.She is staying healthy by exercising physically and doing pelvic floor exercises 2-3 times a week.Overall, the doctor believes the patient is doing well.Her pelvic floor physical therapy has been quite beneficial to her.Her pain has subsided.She still has some bowel difficulties, which the doctor believes would improve with more consistent usage of bowel medications, such as miralax.This could also assist with her rectal discomfort.The doctor suggested that she consider repeating a magnetic resonance imaging merely to reevaluate the pelvic floor and determine where she is in terms of recurring prolapse, and then to continue with physical therapy, avoid straining, and follow-up with the doctor.The patient referred herself to the clinic for nerve damage and pain on (b)(6) 2022.The patient claims that after the transobturator tape was partially removed, she experienced pain, numbness, and nerve damage from the lower abdomen to the clitoris.She also claims that sitting for 30 minutes or more would hurt her back.She reported spontaneous vulvar pain without touch that is intermittent, entry and deep dyspareunia, postcoital pain described as burning irritation for 10 minutes, bilateral inner thigh pain that goes down to her feet and voiding every 2 hours.Exam revealed erythema around gland openings, q-tip tenderness to vestibule, atrophy, no spasm or pelvic floor tenderness, left leg longer than right, mild tenderness with obturator nerve palpation, and pain reproduction with palpation of left pudendal nerve.The assessment included post-mesh vulvar and pelvic pain for which the patient was to increase premarin use; pelvic floor tenderness without spasm possibly due to leg length inequality; mild pudendal neuropathy and possible obturator neuropathy; chronic interstitial cystitis.The patient sought treatment for pudendal neuralgia on (b)(6) 2022.Her present symptoms are suprapubic pressure "like a belt from hip to hip," according to the patient.It improves if she lies down and places a heating pad on it.When she sits up, she feels worse, and when she reclines, she feels slightly better.She can feel something round and hard near her past hysterectomy incision while she's standing, but the pain is more dispersed.Eating, drinking, urinating, or defecating have no impact.There is no relief from voiding.The left side is marginally worse.It hasn't gotten any better in the last two years, and ditropan isn't making things better.This is a challenging condition for this patient, who has long suffered from pelvic pain and pressure, as well as a variety of other symptoms, according to the doctor.It's unclear whether her symptoms have improved or worsened as a result of her previous procedures.She is considering more surgery (removal of the extrapelvic portion of her transobturator mesh.) the likelihood of success with that strategy is difficult to determine.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2016, implant procedure date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.(b)(6).The explanting surgeon is: (b)(6).Block h6: patient code e1405, e2326, e2338, e1301, e2330, e0123,e1309, e020202, e2101, e0126 capture the reported events of dyspareunia, inflammation, swelling/edema, dysuria, pain, nerve damage, urinary retention, depression, adhesions and neuropathy.Impact code f23, f1905, f2303 capture the reported events of unexpected medical intervention, device revision and medication required.Block h10: the complainant indicated that the device is not available for return; therefore, 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 h2: additional information.Blocks b5 (narrative) and h6 (patient codes) has been updated based on the additional information received on september 19, 2023.Correction: block d7a (sud reprocessed and reused?) has been updated.Block b3 date of event: date of event was approximated to september 2, 2016, implant procedure date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).The explanting surgeon is: dr.(b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2101 - adhesions.E2330 - pain.E2320 - dyspareunia.E1301 - dysuria.E1309 - urinary retention.E0123 - nerve damage.E2326 - inflammation.E0126 - neuropathy.E2338 - swelling/edema.E020202 - depression.E1311 - urinary problems.The following imdrf impact codes capture the reportable events of: f2303 - required medication.F23 - unexpected medical intervention.F1905 - device revision or replacement.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - curved device was implanted into the patient during a mid-urethral sling and cystoscopy procedure performed on (b)(6) 2016 for the treatment of stress urinary incontinence.At the end of the cystoscopy, there was no sign of a tumor, carcinoma in situ, stones, or foreign bodies in the bladder.The ureteral orifices were in their usual anatomic location, and clear urine was effluxing bilaterally.The urethra was normal.There were no complications.The procedure was well tolerated by the patient, and she was brought to the recovery room in stable condition.The patient also underwent a hemorrhoidectomy at the same time.On june 25, 2017, the patient states that she was diagnosed with rectal prolapse in 2015 but forgot about it because she underwent rectocele repair in (b)(6) 2015, however she mistook the rectal prolapse for the rectocele surgery and thought it was gone.The patient also had a posterior repair with anal sphincteroplasty in 2004 and reports no stool leakage before or after the surgery.In 2008, she had a supracervical hysterectomy for fibroids, and in 2015, she had a robotic sacrocolpopexy for prolapse.She had a transobturator sling placed for incontinence in september 2016, but she still has incontinence and significant groin discomfort.A hemorrhoidectomy was also performed on the patient.In her recovery, she still experiences pain before, during, and after bowel movements, as well as daily bloating, and she feels a lot of pressure on her pelvic floor.She went to see a doctor for an evaluation of her ongoing symptoms following her most recent operation, and part of the evaluation included a pelvic floor magnetic resonance imaging, which revealed moderate to severe rectal prolapse.Furthermore, the patient reports having stools daily, sometimes twice a day (she feels a lot of pain in her bottom, "like a stick up there"), and having stool residue an hour after her bm.She believes that her frequent bowel movements cause anal fissures.She never loses control of her stool while using the restroom, has normal desires, but suffers from severe back pain.She experiences some soiling where she notices stool when she wipes the next time she uses the toilet, but she does not need to use pads as a result.There were no agents to aid her in emptying her stools.The patient hasn't gone to the bathroom every day since 10 days ago, and it feels like an incomplete emptying, which is bothersome and associated with abdominal bloating.Using toilet takes 5-10 minutes.Reportedly, the patient does not feel a rectum bulge coming out, but she does sense a vaginal rectocele bulge returning.She does have low back pain, which she attributes to the insufficient emptying.She experienced similar back pain following her robotic sacrocolpopexy in 2015.She had a colonoscopy before her robotic sacrocolpoexy, which was normal.She is menopausal and receives estrogen replacement prescription most days of the week.An imaging was performed on (b)(6) 2017 which revealed that the patient is consistent with pelvic floor laxity, including descent of the anorectal junction of up to 6.2cm below the pubococcygeal line indicative of moderate to severe rectal prolapse.Reportedly, the patient has pelvic floor dysfunction with high tone pelvic floor and pain related to recent sling surgery, she has daily bowel movements but feels incomplete stool emptying, bloating.She has no symptoms of a bulge coming through the rectum/anus and we see no external anal prolapse.Magnetic resonance imaging suggests some rectal prolapse but she has no fecal incontinence or severe constipation.The patient is gradually worsening.On (b)(6) 2017, the following symptoms were present during the patient's clinic visit: myalgia of pelvic floor, pelvic pain, complication of other implanted genitourinary mesh and unspecified complication.The patient was last seen by the doctor on (b)(6) 2017, for a follow-up on pelvic pain.According to reports, the patient afterwards had groin pain and was prescribed vaginal valium suppositories as well as physical therapy.The patient has a known history of prolapse as detected by dynamic pelvic magnetic resonance imaging and consulted with two doctors, both of whom agreed that the rectal prolapse was not significant and that there was nothing to be done at this time.She is also working on constipation with them with the use of magnesium.According to the patient, she felt like everything was pulling down on her; she had difficulty taking deep breaths; she felt open down there; she felt like it was raw down there; she had discomfort with the rectocele during intercourse; and she had bloating.She believed that the majority of her issues came after the transobturator was implanted.Many of her problems occur while she is attempting to engage in activities such as yoga and exercise.The patient also tried three different drugs for urge incontinence that were not helpful.She still has some incontinence issues.She was found to have high tone pelvic floor muscles during her evaluation, and she was advised to get nerve blocks and botox trigger point injections.She did not follow up on this, therefore she is presenting it in the clinic for re-evaluation and discussion.Exam revealed high tone pelvic floor muscles right>left; pressure on levators reproduces some of the discomfort she feels with intercourse; no mesh exposure, no pain along the path of the sling or in the groin currently.Recommended pudendal nerve block and trigger point injections (botox) into the pelvic floor before considering mesh removal.On (b)(6) 2018, the patient was seen for an evaluation of possible sling complications and consult for mesh removal.The patient had several complaints, including hamstring tightness, "stomach swelling," bloating, pressure from hip to hip, "difficult breathing" (that preceded the sling).She reported dyspnea with exertion for which she had seen her internist.She also reported back pain and a feeling that everything is "pushing down." she also reported increased fatigue as well as decreased range of motion during yoga - all of which the patient attributed to the sling.Her internist had apparently ruled out lyme/mono and other sources of fatigue and dyspnea.She also reported that since she had the sling, she had not been able to achieve orgasms.She also reported feeling a bulge and thought her rectocele was back.She also reported pressure when she gets up and she has a sense of pressure/urgency.Some mild sui persisted.The patient also experienced pain with sex (entrance and deep dyspareunia).The patient had attended pfpt (pelvic floor physical therapy) for 15 sessions and tried vaginal valium for her symptoms.Physical therapy helped a bit, but valium was not helpful.She has also tried mirabegron (she did not tolerate), ditropan x 1 month without improvement (she also noted dryness).No bladder testing repeated after sling.She had a feeling of incomplete emptying and felt the need to double void.Her previous dynamics mri was essentially normal - without anismus or rectal intussuception.The patient was also experiencing hot flashes, which led to her drinking large volumes of water.Assessment/plan: 1.Pelvic pressure in female: the physician explained to the patient that she had no prolapse, and no evidence of voiding dysfunction.Her symptoms are vague and the physician explained that they may not be related to her transobturator sling.She has tenderness of the pelvic floor muscles, but she has completed pt.Given the concomitant bloating, it may be reasonable for her to seek gi input to r/o ibs or diverticulosis/itis.2.Mixed incontinence: no leaks on pelvic exam.She was drinking large amounts of water, which was likely aggravating her symptoms.Urodynamics/cysto to be repeated given that she also reported sometimes seeing "tissue" in her urine.The physician suspected that she may have detrusor overactivity (do), and she has previously tried 2 oab medications.If testing confirms do, could consider ptns or botox.However, her main complaint at that point seemed to be her pressure and the sensation that everything is "falling." 3.Female dyspareunia: likely partially related to levator spasm.While she is tender at the r puborectalis, the sling itself is not tender and she denies medial thigh pain.4.Bloating: see #1.5.Fecal smearing: see #1.6.Nocturia: behavioral modifications were reviewed in detail including caffeine elimination, timed voids, and fluid restriction.Worksheet given.7.Menopausal hot flushes: the physician advised she discuss this further with her primary gyn as she is consuming large amounts of water for her symptoms.She reports a family history of breast cancer and does not seem interested in local estrogen.The patient had varied symptoms, and the physician believed most were unlikely to be related to the obtryx sling.Further abdominal imaging could be obtained, but the physician thought the likelihood of an ongoing intra-abdominal process was low.Could consider ct with contrast (incl oral) as that could evaluate for diverticular disease and also could possibly see the sacrum (she has back pain but discitis seems unlikely).In the absence of meaningful findings, the phyician continued to discourage sling removal since her symptoms are varied and vague and are not likely to be relieved by sling removal.The physician did explain that a likely outcome of sling removal would be increased incontinence but persistent fatigue/bloating/pressure/dyspareunia/hamstring tightness.Finally, the physician heard wheezing on her lung exam and the patient complained of dyspnea.The physician suggested reevaluation with her pmd or pulmonology (although sp02 normal).On (b)(6) 2018, the patient underwent bilateral pudendal nerve block, trigger point injections into the pelvic floor using botox 100 units due to groin pain and on exam with high tone pelvic floor dysfunction.Operative findings were: normal external female genitalia; adequate support of all vaginal compartments without evidence of prolapse; no evidence of mesh exposure; high tone pelvic floor muscles, right greater than left.During the procedure, after anesthesia was administered, the patient was placed in high dorsal lithotomy position with careful attention paid to leg positioning to ensure there was no hyperextension or hyperflexion of her joints to avoid muscular or neurological damage.Exam-under anesthesia was performed with the findings as noted above.The patient's vagina, perineum, and suprapubic area were prepped and draped in the usual sterile fashion.A surgical time-out was completed in which the patient as well as the procedure was identified and confirmed.They then proceeded with bilateral pudendal nerve blocks.They identified the location of the pudendal nerves bilaterally by palpating the ischial spine and the sacrospinous ligament, using the iowa trumpet to inject 10 ml of the 20 ml solution of 0.5% bupivicaine mixed with 40 mg kenalog 1 cm medial and posterior to the ischial spine on the right side.The same procedure was repeated on the left side injecting the remaining 10 ml of the 20 ml solution of 0.5% bupivicaine mixed with 40 mg kenalog.Next they proceeded with the trigger point injections.100 units of botox was mixed into 10 ml of injectable saline.They palpated tight areas of muscles throughout the levator ani muscles and the obturator internus muscles bilaterally.They injected 3 sites on the right and 2 sites on the left and distributed the 100 unites of botox among these 5 sites using using the iowa trumpet.All instruments were removed from the vagina.The vagina was hemostatic.Counts were correct x2.The patient was taken out of dorsal lithotomy position.The patient tolerated the procedure well.There were no complications.On (b)(6) 2018, the patient states that things have improved slightly following her nerve blocks and botox injections on (b)(6) 2018.She can now do and/or hold various yoga practices that she couldn't before.She is still experiencing pressure and groin pulling.She caught the flu after the botox, which hindered her recovery and made it difficult for her to tell how she was doing at first.She attempted intercourse and had pain upon entering, but things improved after that.Exam revealed high tone pelvic floor muscles right>left but less than prior to botox.The diagnoses were pelvic pain, myalgia or pelvic floor, and muscle spasm.The plan was for the patient to use lidocaine gel prior to intercourse, repeat injections in the future, and keep consult with urogynecologist.On may 17, 2018, the patient reports the following problems during her visit: * mesh problems - the symptoms are reported as being severe.The symptoms occur daily.The location is vagina, aggravating factors include exiting car.Relieving factors include motrin, tylenol.She states the symptoms are chronic and are uncontrolled.* patient presents with complaints of mesh problems.Her main pain symptoms are related to groin pain and the right side is worse than the left.She reports pain with exiting the car as a passenger and a driver.She also reports pain at the top of her vagina.She underwent botox in march for pelvic floor dysfunction.* she reports complaints or urinary leakage with laugh/cough/sneeze.She reports leakage with urgency as well.* she does report a bulge at the entrance to the vagina and believes her rectocele has returned.* she reports occasional fecal incontinence x2 episodes in the last year.She denies constipation.* she is sexually active and reports with pain with intercourse.* she reports dyspareunia which is worse over the last 3 weeks.Review of systems included the following relevant symptoms: dysuria, incomplete emptying, nocturia x 1, urge incontinence, urgency, urinary frequency, depression.Exam revealed pain at the left and right obturator internus muscles, cords lateral to bladder neck.The patient was offered removal of the obtryx sling, paravaginal dissection, urethral lysis, anterior colporrhaphy, and removal of the mesh from the obturators and adductors.On june 20, 2018, the patient was seen for a fifth opinion for mesh removal.Since the obtryx trans-obturator tape in september 2016 the patient feels pain.She has pain in the hips.She feels that her bladder is cut in half and she feels bloating in the abdominal cavity and swelling in the inner thighs.She had seen several specialists at that point.She had seen a physician in january 2018 requesting sling removal but wanted another opinion.She saw another physician who felt the mesh was not causing the pain issues and offered conservative treatment.Then she saw yet another physician, and the patient reported that physician felt the mesh was too high and too tight.The patient wants the mesh removed.Since receiving the mesh sling, the patient felt she had significant symptoms and complications.Sexual symptoms included pain with insertion and even pain with fingering.Her pain was less with deep penetration.She could not orgasm anymore and feels numb and feels g spot no longer exists.Her clitoris was not as sensitive as it used to be, loss sensation even with masturbation.No coital loss of urine.Urinary symptoms include frequent voiding; she does not leak at gym because she voids frequently and sweats during body jam class; wearing pads 3 per day always #2 pads; does not feel she is emptying ok and has to sit for 10 mins and void three times to empty; no utls and no hematuria.Post void residual was 150 ml as measured by straight catheterization.Bowel symptoms: bms at least 4 per week; feels rectocele is impacting.Last colonoscopy age 49 wnl.She reported that the recent levator botox injection march 1, 2018 did not alleviate her symptoms.Review of systems was positive for fever, weight gain, chest pain, sob, nausea, abdominal pain, gerd, back pain, joint pain, skin rash, brsing, anemia, hayfever side stitch or something or a certain yoga position will cause her not to be able to catch her breath--short lived and feels everything is being dragged and mal-aligned due to the sling the patient desired sling mesh removal with bilateral groin dissection.The physician wanted to review urodynamics and schedule cystoscopy and preop discussion.On (b)(6) 2018, the patient had an office visit for a preop discussion.The patient is s/p obtryx ii transobturator tape sept 2016 and also s/p sept 2015 robotic sacrocolpopexy, posterior repair, urethrolysis, right salpingo-oophorectomy, excision of endometriosis implants.Cystoscopy performed july 12, 2018 showed no mesh erosion.The patient reported that prior to sling surgery in (b)(6) 2016, she had a groin pain and felt she pulled a muscle.She was told she would get the retropubic sling avoiding the groin.The day of surgery, the patient reports the plan changed and she received the transobturator sling instead.(patient signed consent for transobturator) since the operative, patient has had significant dyspareunia and bladder pain.Patient reported she feels as if she is being "strangled at the pubic bone" and pain that is in a belt like distribution from hip to hip.Patient reports at times the pain causes her to not be able to breathe.Patient feels pain at the vaginal incision site.Feels pain at the top of her vagina.Due to the pain, the patient previously saw another healthcare provider, but did not get mesh removed.The patient reported she was leaking worse than she did prior to surgery.Patient wears pads every day.Assessment/plan 1.Complication of implanted vaginal mesh t85.9xxa dyspareunia, bladder pain s/p obtryx ii transobturator sling placement in sept 2016; cystoscopy showed no mesh erosion ((b)(6) 2018) patient counseled that the healthcare provider would remove the mesh transvaginally and through the groin; patient and partner asked appropriate questions regarding procedure; patient told that 1-2% of patients have complications from the mesh; small percentage of people who when they take out the mesh the scar tissue prevents leakage but there is a possibility she would have recurrent stress incontinence and also persistent pain after the surgery 2.Female dyspareunia n94.10.See #1.Obtryx ii removal surgery, tentative date: (b)(6) 2018; holding the date for now will f/u with pre-op (after (b)(6) 2018).Risks- incomplete removal, persistent pain, potential to leak again.Attending physician's impressions: 30 mins spent with patient and husband; will consider options and return for final preop.On (b)(6) 2019, the patient underwent an intraoperative ultrasound guidance, removal of vaginal sling, anterior repair, laparoscopic ureterolysis and enterolysis.During the intraoperative ultrasound guidance, the used a bk3000 ultrasound machine and localized the sling location and extent.It was noted that on the right side, there were some hyperechoic areas and density close to the ischiopubic rami where the patient had pain.This area was tucked.During the surgery, the distal margin of the suburethral region was incised.With 10 ml of marcaine, this was hydrodissected.The vaginal epithelium was cephalad expanded and sliced in the midline.The underlying tissue was separated from the vaginal epithelium.They carefully dissected upward.The blue-colored sling was in the deeper layers, and it appeared to be roiled under anesthesia.This was undermined, and the sling was localized in the midline, grabbed with two kocher clamps, and separated in the center, providing quick relief.Lateral dissection was performed to the margins of the ischiopubic rami.The sling was strongly adherent to the right ischiopubic rami on the right side and they freed it and were able to release it from the obturator fossa by tugging cephalad.The sling on the left side was going more cephalad and not straight into the obturator fossa, but rather into the levator, and this was also removed completely.Anterior repair was performed by plicating pubourethral ligaments tied %2 using 2-0 pds sutures under the urethra to provide support to hopefully prevent patient's subsequent stress urinary incontinence.The vaginal epithelium was a slightly trimmed and closed in the midline using 2-0 vicryl in running fashion.They performed a laparoscopy and noticed that the distance between the pubic bone and the umbilicus was narrow, hence they chose a supraumbilical route given the nature of the patient's pain.Marcaine (5 ml) was then injected into to the affected area.After inserting a veress needle in this location, the abdomen was insufflated with 3 liters of normal saline.In a neurovascularly safe manner, a 5-mm trocar was placed.A scan of the pelvic cavity revealed the sacrocolpopexy mesh, with a small bowel loop adhering to the center of it.A 5-mm trocar was inserted in the right lower quadrant, an 11-mm in the left lower quadrant, and another 5 mm in the left lower quadrant medial to the inferior epigastric vessels.The dissection was done to free up the small bowel and open a peritoneal window for ureterolysis while keeping the right ureter protected from the area of dissection.After opening the peritoneal window, they noticed that the ureter was at a safe distance on the right side.The colon was meticulously dissected, and the adherent area of the bowel to the mesh, which was a thick scar band, was located, coagulated, and subdivided using the ligasure device.Further dissection was performed to free up the bowel from the mesh region.To avoid future adhesion, they placed a seprafilm over the dissection site.The 11-mm trocar site was closed with 0 vicryl utilizing a carter-thomason device.The skin was closed subcuticularly with 4-0 monocryl.Dermabond adhesive was used.A cystoscopy was conducted, which demonstrated good urine outflow from both sides.The procedure was well tolerated by the patient.The patient's condition was reviewed with the patient's husband, who was pleased.The rest of the peritoneal cavity exhibited normal anatomy as well.On (b)(6) 2019, the patient was seen for swelling and inflammation at the area of her mesh removal and painful bowel movements.On (b)(6) 2020, the patient had cystometrogram which showed no sui with cough, sitting, or standing; no leaking with valsalva; urgency with sensation of water, no leaking; and no retention.On (b)(6) 2020, the patient presents to the clinic for referral request for echocardiogram and she is also requesting to see a urogynecologist who performs mesh removal.Reportedly, the patient still has some pelvic and sacral pain despite previous surgery in addition to occasional dysuria, urgency, and incontinence.The patient was referred to a urogynecologist.On (b)(6) 2020, the patient complains of having her rectum squeezed and her bowels being quite noisy in the morning.She does state that when she moves her bowels, she experiences sharp pains, and her bowel movements are still episodic, with days when she needs to take miralax or another type of stool softener to assist herself pass.She underwent a colonoscopy a year ago, and everything appeared to be fine.Basically, she's here for a follow-up.She is staying healthy by exercising physically and doing pelvic floor exercises 2-3 times a week.Overall, the doctor believes the patient is doing well.Her pelvic floor physical therapy has been quite beneficial to her.Her pain has subsided.She still has some bowel difficulties, which the doctor believes would improve with more consistent usage of bowel medications, such as miralax.This could also assist with her rectal discomfort.The doctor suggested that she consider repeating a magnetic resonance imaging merely to reevaluate the pelvic floor and determine where she is in terms of recurring prolapse, and then to continue with physical therapy, avoid straining, and follow-up with the doctor.The patient referred herself to the clinic for nerve damage and pain on (b)(6) 2022.The patient claims that after the transobturator tape was partially removed, she experienced pain, numbness, and nerve damage from the lower abdomen to the clitoris.She also claims that sitting for 30 minutes or more would hurt her back.She reported spontaneous vulvar pain without touch that is intermittent, entry and deep dyspareunia, postcoital pain described as burning irritation for 10 minutes, bilateral inner thigh pain that goes down to her feet and voiding every 2 hours.Exam revealed erythema around gland openings, q-tip tenderness to vestibule, atrophy, no spasm or pelvic floor tenderness, left leg longer than right, mild tenderness with obturator nerve palpation, and pain reproduction with palpation of left pudendal nerve.The assessment included post-mesh vulvar and pelvic pain for which the patient was to increase premarin use; pelvic floor tenderness without spasm possibly due to leg length inequality; mild pudendal neuropathy and possible obturator neuropathy; chronic interstitial cystitis.The patient sought treatment for pudendal neuralgia on (b)(6) 2022.Her present symptoms are suprapubic pressure "like a belt from hip to hip," according to the patient.It improves if she lies down and places a heating pad on it.When she sits up, she feels worse, and when she reclines, she feels slightly better.She can feel something round and hard near her past hysterectomy incision while she's standing, but the pain is more dispersed.Eating, drinking, urinating, or defecating have no impact.There is no relief from voiding.The left side is marginally worse.It hasn't gotten any better in the last two years, and ditropan isn't making things better.This is a challenging condition for this patient, who has long suffered from pelvic pain and pressure, as well as a variety of other symptoms, according to the doctor.It's unclear whether her symptoms have improved or worsened as a result of her previous procedures.She is considering more surgery (removal of the extrapelvic portion of her transobturator mesh.) the likelihood of success with that strategy is difficult to determine.Boston scientific received an additional information on november 11, 2022 as follows: on (b)(6) 2018, the patient called the health care facility and would like to see a surgeon to have her pelvic mesh removed.On (b)(6) 2018, the patient thinks that her pain has now reached the bottom of her feet.The patient has been using aspercreme on her feet and using some heel cushions with slight improvement.The patient has new shoes, but they have not resolved the pain.Moreover, the patient is working with specialists to have her pelvic mesh removed as swelling in the lateral epicondylalgia and abdominal region has been constant and increases when she does her knee exercises.Furthermore, the patient had plantar fascial fibromatosis.Reportedly, her symptoms are due to kinematic challenges starting in the pelvis and going down through the knees and feet.She was in the home program and management.Additionally, the patient presented the following problems: *presbyopia.*low back pain.*pain in unspecified knee.*unspecified urinary incontinence.*pain in right shoulder.*gastroesophageal reflux disease without esophagitis.*osteopenia.*breast fibrocystic disease.On (b)(6) 2019, the patient complains of swelling in her right breast and does not know how long it has been there.She states that she has had ongoing blood pressure fluctuations since the procedure for her mesh removal.Her blood pressure readings have varied, from systolic up to 150.Reportedly, the patient is back to doing yoga again.Her pressure is in the epigastrium; there is no reflux or nausea.On (b)(6) 2020, the patient comes at the clinic with a cardiologist referral request for an echocardiography.The patient also wants to consult a urogynecologist who can remove mesh.According to reports, the patient had two mesh slings inserted for bladder incontinence, which were causing severe gastrointestinal issues.She also had some mesh removed by a surgeon in virginia, but not all of it.Despite the previous surgery, she still has some pelvic and sacral pain.The patient thinks she has facet arthritis in addition to normal osteoarthritis as of (b)(6) 2020.She had various problems with her urethral sling in 2016, which affected her back.According to reports, the left half of the mesh was removed because it was excessively tight and pulled forward.The patient believes she cannot walk regularly or comfortably.She has been doing yoga and pilates to cope with the pain and will continue to do so.The patient also stated that being more active made her feel better.Objective/examination: posture sitting: frequent moving.Demonstrates she feels most comfortable sitting equal and supported.Standing: unremarkable.Gait: within normal limits, slight forward lean and feel of pelvis pulling in intermittently.Functional activity: air squat: femurs to parallel, feels like her back is being pulled in and down.The patient tolerated treatment well.Prognosis: good with continued physical therapy treatment and adherence to home exercise program.Diagnosis: low back pain.Functional limitations include: reduced core strength, specifically in rotational and side strength.Sensation of internal tightness in pelvis.Will benefit from home exercise program and graded return to more activity to improve comfortably with movement.Boston scientific received additional information on september 19, 2023, as follows: during the patient's clinic visit on (b)(6) 2017, she reported experiencing pain and pressure following surgery.The patient mentioned experiencing lower back pain, dyspareunia, and low abdominal pain for the past year.There were no reports of hematuria, but the patient did mention experiencing urinary problems.On (b)(6) 2019, the patient had a fluoroscopic small bowel series, which showed a normal caliber of the small bowel.The transit time is mildly accelerated with barium into the splenic flexure by 50 minutes.The small bowel mucosal fold pattern is normal, and there is no obstruction or abnormal displacement of small bowel loops.The patient reported bloating mainly in the left lower quadrant, but no abnormality was seen in that area.

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Brand Name

OBTRYX II SYSTEM - CURVED

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

15508556

MDR Text Key

300878167

Report Number

3005099803-2022-05529

Device Sequence Number

Product Code

OTN

UDI-Device Identifier

08714729839255

UDI-Public

08714729839255

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

Reporter Occupation

Other

Type of Report

Initial,Followup,Followup,Followup

Report Date

10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

09/29/2022

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Expiration Date

07/22/2019

Device Model Number

M0068504110

Device Catalogue Number

850-411

Device Lot Number

0000037832

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Date Manufacturer Received

09/19/2023

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Date Device Manufactured

07/22/2016

Is the Device Single Use?

Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Required Intervention;

Patient Age

49 YR

Patient Sex

Female

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

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