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

Patient Problems Bacterial Infection (1735); Flatus (1865); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Burning Sensation (2146); Urinary Frequency (2275); Injury (2348); Numbness (2415); Prolapse (2475); Dysuria (2684); Paresthesia (4421); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Fecal Incontinence (4571); Insufficient Information (4580)

Event Date 07/07/2018

Event Type Injury

Manufacturer Narrative

Date of event was approximated to (b)(6) 2018, implant date, as no event date was reported.(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

It was reported to boston scientific corporation that an obtryx ii system - halo device was 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: block e1 (below) 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 device was implanted at(b)(6) block h6: patient code 2348 captures the reportable event of unspecified injury.Conclusion code 4316 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

It was reported that an obtryx ii system - halo device was implanted into the patient during a hysterectomy with ovarian sparing, anterior/posterior repair procedure on (b)(6) 2018 for the treatment of cystocele/rectocele.Patient had suture removal on (b)(6) 2018 and physician came to the conclusion that the pudendal nerve may have been sutured to the ligament.On (b)(6) 2018, patient presented with with numbness and hypersensitivity.She feels numbness and pain in the rectal area.She also has numbness and pain just on the right side of her labia and inner thigh.Patient is unable to sit especially if the right leg is stretched out.Patient was put on gabapentin but did not feel that it was doing much so she is no longer taking it.On (b)(6) 2019, patient presented occasional clitoral burning and she can no longer have an orgasm.The patient notes incontinence of flatus and occasionally of stool.She also will occasionally have burning pain after a bowel movement.All of these symptoms were new onset after the sacrospinous fixation.On (b)(6) 2020, patient presented symptoms left.She has also noted some radiating pain down the posterior medial thigh, right greater than left.At her prior evaluation, the tvt-o mesh was not tender to palpation.She had attempted intercourse and noted vaginal bleeding afterwards.She also had extreme pain.On (b)(6) 2020, patient has undergone tvt-o mesh excision, both vaginal and both groin segments.

Manufacturer Narrative

Additional information as of 14jan2022: block b3 date of event: date of event was approximated to april 20, 2018, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The device was implanted at (b)(6).Block h6: patient codes e1405, e2333, e232401, e1901, e2330 and e0123 captures the reportable event of dyspareunia, prolapse, fecal incontinence, bacterial infection, pain and nerve damage.Impact codes f1903 and f2303 captures the reportable events of device explantation and medication required.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.

Manufacturer Narrative

Correction: blocks b3, b5, e4 and h6: patient codes and impact codes.Block b3 date of event: date of event was approximated to (b)(6), 2018, the date symptoms were first noted, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The device was implanted at (b)(6) hospital.Block h6: patient codes e1405, e2333, e232401, e1901, e2330 and e0123 captures the reportable event of dyspareunia, prolapse, fecal incontinence, bacterial infection, pain and nerve damage.Impact codes f1903, f2303 and f1202 capture the reportable events of device explantation,medication required and inability to work or perform some daily activities.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

Manufacturer Narrative

Block b5 has been updated based on the information received on november 8 and 22, 2022.Block b3 date of event: date of event was approximated to july 07, 2018, the date symptoms were first noted, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.Jennifer m.Donofrio elliot health system, manchester, new hampshire block h6: patient codes e1405, e2333, e232401, e1901, e2330, e0123, e1309, e0126, e1301 and e2326 capture the reportable event of dyspareunia, prolapse, fecal incontinence, bacterial infection, pain and nerve damage, urinary retention, neuropathy, dysuria and inflammation.Impact codes f1903, f2303, f1202 and f23 capture the reportable events of device explantation, medication required, inability to work or perform some daily activities and nerve block.

Event Description

It was reported that an obtryx ii system - halo device was implanted into the patient during a procedure performed on (b)(6) 2018.As reported by the patient attorney, the patient has experienced an unspecified injury.Boston scientific has been unable to obtain additional information regarding the event to date.Any follow - up regarding this event will be handled by bsc legal.The device was implanted and is not expected to be returned.Additional information received on 14jan2022.It was reported that an obtryx ii system - halo device was implanted into the patient during a hysterectomy with ovarian sparing, anterior and posterior repair procedure on (b)(6) 2018 for the treatment of cystocele and rectocele.Medical and surgical history included hernia repair, lyme disease and possible chronic epstein - barr virus, chronic bacterial vaginosis, smoking, two vaginal births with episiotomies.Patient had sacrospinous sutures removal on (b)(6) 2018 and physician came to the conclusion that the pudendal nerve may have been sutured to the ligament.On (b)(6) 2018, patient presented for physical therapy evaluation.She reported numbness and hypersensitivity.She feels numbness and pain in the rectal area.She also has numbness and pain just on the right side of her labia and inner thigh.Patient is unable to sit especially if the right leg is stretched out.Patient was put on gabapentin but did not feel that it was doing much so she is no longer taking it.She had some improvement in her symptoms right after suture removal in may, but she now has some good days and some bad days.She reported difficulty with bowel movements and bowel urgency, needing to concentrate to urinate, dyspareunia, and inability to work or perform some daily activities secondary to pain.Exam revealed lumbar paraspinals and ql on the right are moderately tight; patient is hypersensitive along the right inner thigh - adductors; buttock, she can barely tolerate light palpation to this area without severe increase in pain; external palpation of the obturator is very uncomfortable for patient - she cannot tolerate light touch.On (b)(6) 2019, patient presented for preadmission history and physical related to right - sided pudendal neuralgia and fecal incontinence.The patient noted numbness in the vaginal area on the right side, which quickly progressed to vaginal and rectal pain.The patient also has pain in the buttock area and the back of the thigh.She had the sacrospinous sutures removed on (b)(6) 2018, which yielded some improvement in pain.The patient is still highly symptomatic.She had 3 pudendal nerve blocks with temporary pain relief only; it did not relieve the buttock pain.Her rectal pain is somewhat reduced.She notes significant pain with sitting.She also has deep - seated vaginal pain and labial pain.She has occasional clitoral burning.She can no longer have an orgasm.The patient notes reduced urinary stream, but no leakage.The patient notes significant urinary frequency.The patient also notes incontinence of flatus and occasionally of stool.She also will occasionally have burning pain after a bowel movement.All of these symptoms were new onset after the sacrospinous fixation.The impression was right - sided pudendal neuralgia and neuropathy secondary to the sacrospinous fixation.The patient underwent right - sided transgluteal pudendal nerve decompression.On (b)(6) 2020, patient presented with persistent right - sided pudendal nerve pain and some symptoms on her left.She has also noted some radiating pain down the posterior medial thigh, right greater than left.At her prior evaluation, the tvt - o mesh was not tender to palpation.She had attempted intercourse and noted vaginal bleeding afterwards.She also had extreme pain.The patient denied any significant urinary or defecatory complaints.Exam revealed that both arms of the tvt - o mesh were exquisitely tender to palpation.The impression was persistent right - sided pudendal neuralgia, which has not improved since her nerve decompression.However, now she has significant tenderness with obturator neuralgia secondary to the transvaginal tension - free vaginal tape - obturator mesh.This seems to be worse on the right than the left and most likely is contributing to some of her pudendal nerve symptoms as well.Also, she is starting to get symptoms on the left, which she did not have in the past.On (b)(6) 2020, the patient underwent tvt - o mesh excision, both vaginal and both groin segments.The mesh was completely excised.The pathology of the mesh specimen was dense fibrous tissue and focal skeletal muscle, with foreign body - type giant cell reaction and polarizable foreign body, consistent with mesh.Additional information received on september 27, 2022.On (b)(6) 2018, patient had urology consultation for pudendal neuralgia and underwent right transvaginal pudendal nerve block.She presented with concerns of right buttock pain.The symptoms began after she underwent a sacral spinous ligament fixation april of this year.The sacral spinous ligament fixation was done in conjunction with a vaginal hysterectomy and tvt for prolapse.Shortly after the procedure, secondary to ongoing pain, the patient underwent a sacrospinous ligament suture release and excision on (b)(6) 2018.Unfortunately, pain still continued despite this.She described no urinary symptoms.Her stress incontinence had resolved.She had not had any bowel concerns although admitted to worsening of her sensation of burning and pain during a bowel movement.Intercourse and sitting could flare her symptoms significantly as well as engaging in vigorous activity.The patient had been on gabapentin although this had not been helpful but found this sedating.She had been doing physical therapy.Assessment and plan: 1.Pudendal neuralgia.Patient with right pudendal nerve entrapment and injury now with residual right - sided pudendal neuralgia.Good response to pudendal nerve block.Recommendations: continue physical therapy but avoid tens or other exercised that engage in strengthening the core.Consider gabapentin daily orally rather than as needed.Start topical lidocaine vaginally as directed.Reevaluate symptoms in the next 4 weeks.Consider repeat pudendal nerve block then.Procedure: right transvaginal pudendal nerve block.1percent lidocaine using iowa trumpet palpation of ischial spine transvaginally 1cm medial and inferior.Minimal vaginal bleeding post injection.Perineal numbness attained immediate improvement of pain no immediate side effects noted.Patient tolerated procedure well without complication.On (b)(6) 2018, progress notes reported the patient was complaining of uterine prolapse with stress urinary incontinence.The patient noted reduced urinary stream but no leakage.She did not appear to have a residual.Occasionally, she noted some dysuria.The patient noted significant urinary frequency, but also drinks a large amount of water per day.The patient now notes incontinence of flatus and occasionally of stool.This is a new problem the patient also notes burning pain after bowel movement.The patient had none of these symptoms prior to her sacrospinous fixation.Physical exam resulted patient appeared uncomfortable standing.On (b)(6) 2019, progress notes stated right - sided pudendal neuralgia and neuropath as chief complaint.She noted little to no change in symptoms since the right - sided transgluteal pudendal nerve decompression in (b)(6) 2019.She continued to have issues with anal rectal pain but also some numbness.The patient also had some seepage of stool.The patient continued to have very poor sitting tolerance.Was getting some physical therapy but no internal treatment.She was on gabapentin which was helpful for her pain but would like to be on a different medication.Recommended she consider seeing a therapist with more experience with pudendal neuralgia such as falguni vashi.Also recommended to see medical pain management specialist for questions as well as for series of pudendal nerve blocks and pfcn blocks - posterior femoral cutaneous nerve.Patient could be a candidate for a nerve ablation procedure for the pfcn.On (b)(6) 2020, it was reported in a progress note that the patient continued to have pudendal pain as well as obturator nerve pain.She was concerned that perhaps the tvt - o mesh was causing some of her persistent symptoms.The patient also had attempted intercourse and noted vaginal bleeding afterwards.She also had extreme pain.She then used some estrace cream and denied any further bleeding.The patient was scheduled for her 1st pudendal nerve blocks next week.An obturator nerve block or a posterior femoral cutaneous nerve block may be performed as well.These would be done on the right side only.It would appear that the arms of the mesh were also contributing to her pudendal symptoms both in the right and now on the left.The patient will continue the use of the estrace cream and follow up for bilateral pudendal nerve blocks as well as right - sided obturator in posterior femoral cutaneous nerve blocks.The patient may have to consider transvaginal mesh excision with a right groin exploration with mesh excision in the future.On (b)(6) 2020, the patient had obturator nerve block and tolerated the procedure well.The patient was discharged to home on the same day and was very pleased with the results.Tailbone felt much better.History of present illness: numbness and tingling: right rectum, sometimes vulva.Bowel and bladder: some urinary retention.Assessment and plan: status post right pudendal nerve decompression with severe pain, vaginal scarring and inability to sit.Discussed multimodal options for pain control.Pertinent problems and diagnosis include: right greater than left pudendal neuralgia after hysterectomy.Status post right pudendal nerve decompression (b)(6) 2019.Right obturator neuralgia.Pfcn posterior femoral cutaneous nerve.Pelvic floor scarring and spasm, unable to penetrate vagina.Left hip bursitis.Tobacco.Opted not to try the pudendal nerve block.Patient needed to have the bladder sling and mesh removed.She was given anesthetic today and had immediate relief.If no plans for surgery, patient can have a repeat of steroid if no prolonged relief and good relief with local anesthetic.Additional information received on november 8 and 22, 2022.In a progress note of (b)(6) 2018, patient reported that she was feeling great, no other pain.She had been doing activities around the house including washing and waxing her car, washing windows and running multiple errands at a time, walked to mailbox 400 yards daily, sleeping was fine.She was not on any pain medication except occasional advil before bed.However, she had pain with passing firm stool, so she was taking colace, prunes and prune juice to keep her bowel movement soft.Passing loose or firm stool is not difficult.No incontinence of stool.She has perineal numbness to the right of the rectum onto the inner buttocks.The labial numbness is now hypersensitive.In a rehabilitation note dated (b)(6) 2018, patient was reported to experience lumbopelvic pain since her hysterectomy and vaginal sling in april.Due to this, the patient suffered primary functional limitations such as sitting, standing for extended periods of time, squatting, and walking distances.Planned treatment were lumbo sacral mobilization, down training to reduce extra sensitive nerves, manual joint and soft tissue mobilization and stretching once the musculoskeletal assessment completed.On (b)(6) 2018, she had her second nerve block when she was referred for physical therapy to address her pelvic pain.Plan of care: short term goals: 1.Reduce myofascial tension in the abdominal fascia from moderate to minimum to allow patient to optimally contract and relax her pelvic floor muscles in 4 weeks.2.Good proximal le muscle flexibility in the posterolateral hip muscles to be indicated as minimal tension in piriformis and at least 90 degrees of hamstring length to reduce tension on the pelvis and optimize pelvic floor contractions in 4 weeks.Long term goals: 1.Patient specific functional scale to be rated all categories at 6 or above in 8 weeks.2.Will demonstrate symmetrical lumbosacral ligaments and joints to allow her to sit for 30 mins comfortably in 8 weeks.Patient reported mesh removal helped but she was having more incontinence issues.She was not able to wear underwear because of pain.She was interested in getting another nerve block and when done, she was hoping physical therapy might be effective.After mesh removal, she was overall improved but still with numbness in certain areas and hypersensitivity in right inner thigh and back of the thigh and vagina.She hoped to improve her sitting so that she can stress her hip less.Discussed strategies for left hip bursitis but topicals ice and heat had not been helpful.The patient was encouraged to restart physical therapy.Her symptoms may improve with time as the nerves heal after surgery.Plan.1.Follow up: right pudendal and right obturator nerve block 2.Interventions: right transgluteal pudendal nerve block and posterior femoral cutaneous nerve block for symptomatic relief.Consider right obturator nerve block.Consider right ls and 52 dorsal root ganglion stimulators to target the perineum and back of leg, she was concerned about foreign body reaction.Transvaginal pudenda! nerve blocks temporary relief of perinea! pain.Status post right pudenda! nerve decompression.On (b)(6) 2020, patient presented for follow up after the right obturator and right pudendal nerve block which was 80 percent relief for one and a half weeks.Described painful numbness posterior to anus close to sacrum.Pain was worse after bowel movement and primarily right side.Discussed that spinal stimulation may not address the numbness but may address her pain and with right groin pain.Before proceeding with spinal cord stimulation trial, will need: pelvic mri to rule out tarlov cyst or other pathology given persistent symptoms.Lumbar x - ray to rule out l 1 foraminal stenosis.Pain psychology spinal cord stimulation evaluation.She continued to have up to 9 of 10 post - surgical obturator and pudenda or neuralgia and complications from vaginal.Mesh, had tried physical therapy for many months, injection therapy, pudenda or nerve decompression but was unable to be physically active.Virtual follow up after pelvic mri, lumbar x - ray, and psychology screen.On (b)(6) 2021 the patient presented for a office visit.Rectal and vaginal pain continues and she reports fecal incontinence especially when in pain.Urinary incontinence is still present.The patient would like to discuss options going forward.In the physician assessment, there is still a possibility that the patient will improve within the next year from the surgical procedure and physical therapy.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2018, the date symptoms were first noted, 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).Block h6: imdrf patient codes e1405, e2333, e232401, e1901, e2330, e0123, e1309, e0126, e1301 and e2326 capture the reportable event of dyspareunia, prolapse, fecal incontinence, bacterial infection, pain and nerve damage, urinary retention, neuropathy, dysuria and inflammation.Imdrf impact codes f1903, f2303, f1202 and f23 capture the reportable events of device explantation, medication required, inability to work or perform some daily activities and nerve block.

Event Description

It was reported that an obtryx ii system - halo device was 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.Any follow - up regarding this event will be handled by bsc legal.The device was implanted and is not expected to be returned.Additional information received on 14jan2022.It was reported that an obtryx ii system - halo device was implanted into the patient during a hysterectomy with ovarian sparing, anterior/posterior repair procedure on (b)(6) 2018 for the treatment of cystocele/rectocele.Medical and surgical history included hernia repair, lyme disease and possible chronic epstein - barr virus, chronic bacterial vaginosis, smoking, two vaginal births with episiotomies.Patient had sacrospinous sutures removal on may 10, 2018 and physician came to the conclusion that the pudendal nerve may have been sutured to the ligament.On (b)(6)2018, patient presented for physical therapy evaluation.She reported numbness and hypersensitivity.She feels numbness and pain in the rectal area.She also has numbness and pain just on the right side of her labia and inner thigh.Patient is unable to sit especially if the right leg is stretched out.Patient was put on gabapentin but did not feel that it was doing much so she is no longer taking it.She had some improvement in her symptoms right after suture removal in may, but she now has some good days and some bad days.She reported difficulty with bowel movements and bowel urgency, needing to concentrate to urinate, dyspareunia, and inability to work or perform some daily activities secondary to pain.Exam revealed lumbar paraspinals and ql on the right are moderately tight; patient is hypersensitive along the right inner thigh - adductors; buttock, she can barely tolerate light palpation to this area without severe increase in pain; external palpation of the obturator is very uncomfortable for patient - she cannot tolerate light touch.On (b)(6)2019, patient presented for preadmission history and physical related to right - sided pudendal neuralgia and fecal incontinence.The patient noted numbness in the vaginal area on the right side, which quickly progressed to vaginal and rectal pain.The patient also has pain in the buttock area and the back of the thigh.She had the sacrospinous sutures removed on (b)(6)2018, which yielded some improvement in pain.The patient is still highly symptomatic.She had 3 pudendal nerve blocks with temporary pain relief only; it did not relieve the buttock pain.Her rectal pain is somewhat reduced.She notes significant pain with sitting.She also has deep - seated vaginal pain and labial pain.She has occasional clitoral burning.She can no longer have an orgasm.The patient notes reduced urinary stream, but no leakage.The patient notes significant urinary frequency.The patient also notes incontinence of flatus and occasionally of stool.She also will occasionally have burning pain after a bowel movement.All of these symptoms were new onset after the sacrospinous fixation.The impression was right - sided pudendal neuralgia and neuropathy secondary to the sacrospinous fixation.The patient underwent right - sided transgluteal pudendal nerve decompression.On (b)(6)2020, patient presented with persistent right - sided pudendal nerve pain and some symptoms on her left.She has also noted some radiating pain down the posterior medial thigh, right greater than left.At her prior evaluation, the tvt - o mesh was not tender to palpation.She had attempted intercourse and noted vaginal bleeding afterwards.She also had extreme pain.The patient denied any significant urinary or defecatory complaints.Exam revealed that both arms of the tvt - o mesh were exquisitely tender to palpation.The impression was persistent right - sided pudendal neuralgia, which has not improved since her nerve decompression.However, now she has significant tenderness with obturator neuralgia secondary to the transvaginal tension - free vaginal tape - obturator mesh.This seems to be worse on the right than the left and most likely is contributing to some of her pudendal nerve symptoms as well.Also, she is starting to get symptoms on the left, which she did not have in the past.On (b)(6)2020, the patient underwent tvt - o mesh excision, both vaginal and both groin segments.The mesh was completely excised.The pathology of the mesh specimen was dense fibrous tissue and focal skeletal muscle, with foreign body - type giant cell reaction and polarizable foreign body, consistent with mesh.Additional information received on 27sep2022.On (b)(6)2018, patient had urology consultation for pudendal neuralgia and underwent right transvaginal pudendal nerve block.She presented with concerns of right buttock pain.The symptoms began after she underwent a sacral spinous ligament fixation april of this year.The sacral spinous ligament fixation was done in conjunction with a vaginal hysterectomy and tvt for prolapse.Shortly after the procedure, secondary to ongoing pain, the patient underwent a sacrospinous ligament suture release and excision on (b)(6)2018.Unfortunately, pain still continued despite this.She described no urinary symptoms.Her stress incontinence had resolved.She had not had any bowel concerns although admitted to worsening of her sensation of burning and pain during a bowel movement.Intercourse and sitting could flare her symptoms significantly as well as engaging in vigorous activity.The patient had been on gabapentin although this had not been helpful but found this sedating.She had been doing physical therapy.Assessment/plan: 1.Pudendal neuralgia.Patient with right pudendal nerve entrapment/injury now with residual right - sided pudendal neuralgia.Good response to pudendal nerve block.Recommendations: continue physical therapy but avoid tens or other exercised that engage in strengthening the core.Consider gabapentin daily orally rather than as needed.Start topical lidocaine vaginally as directed.Reevaluate symptoms in the next 4 weeks.Consider repeat pudendal nerve block then.Procedure: right transvaginal pudendal nerve block.1% lidocaine using iowa trumpet palpation of ischial spine transvaginally 1cm medial and inferior.Minimal vaginal bleeding post injection.Perineal numbness attained, immediate improvement of pain no immediate side effects noted.Patient tolerated procedure well without complication.On (b)(6)2018, progress notes reported the patient was complaining of uterine prolapse with stress urinary incontinence.The patient noted reduced urinary stream but no leakage.She did not appear to have a residual.Occasionally, she noted some dysuria.The patient noted significant urinary frequency, but also drinks a large amount of water per day.The patient now notes incontinence of flatus and occasionally of stool.This is a new problem the patient also notes burning pain after bowel movement.The patient had none of these symptoms prior to her sacrospinous fixation.Physical exam resulted patient appeared uncomfortable standing.On (b)(6)2019, progress notes stated right - sided pudendal neuralgia/neuropath as chief complaint.She noted little to no change in symptoms since the right - sided transgluteal pudendal nerve decompression in march 2019.She continued to have issues with anal rectal pain but also some numbness.The patient also had some seepage of stool.The patient continued to have very poor sitting tolerance.Was getting some physical therapy but no internal treatment.She was on gabapentin which was helpful for her pain but would like to be on a different medication.Recommended she consider seeing a therapist with more experience with pudendal neuralgia such as falguni vashi.Also recommended to see medical pain management specialist for questions as well as for series of pudendal nerve blocks and pfcn blocks (posterior femoral cutaneous nerve).Patient could be a candidate for a nerve ablation procedure for the pfcn.On (b)(6)2020, it was reported in a progress note that the patient continued to have pudendal pain as well as obturator nerve pain.She was concerned that perhaps the tvt - o mesh was causing some of her persistent symptoms.The patient also had attempted intercourse and noted vaginal bleeding afterwards.She also had extreme pain.She then used some estrace cream and denied any further bleeding.The patient was scheduled for her 1st pudendal nerve blocks next week.An obturator nerve block or a posterior femoral cutaneous nerve block may be performed as well.These would be done on the right side only.It would appear that the arms of the mesh were also contributing to her pudendal symptoms both in the right and now on the left.The patient will continue the use of the estrace cream and follow up for bilateral pudendal nerve blocks as well as right - sided obturator in posterior femoral cutaneous nerve blocks.The patient may have to consider transvaginal mesh excision with a right groin exploration with mesh excision in the future.On (b)(6)2020, the patient had obturator nerve block and tolerated the procedure well.The patient was discharged to home on the same day and was very pleased with the results.Tailbone felt much better.History of present illness: numbness/tingling: right rectum, sometimes vulva.Bowel and bladder: some urinary retention.Assessment and plan: status post right pudendal nerve decompression with severe pain, vaginal scarring and inability to sit.Discussed multimodal options for pain control.Pertinent problems/diagnosis include: right greater than left pudendal neuralgia after hysterectomy, status post right pudendal nerve decompression in march 2019, right obturator neuralgia, pfcn posterior femoral cutaneous nerve, pelvic floor scarring and spasm, unable to penetrate vagina, left hip bursitis, tobacco.Opted not to try the pudendal nerve block.Patient needed to have the bladder sling and mesh removed.She was given anesthetic today and had immediate relief.If no plans for surgery, patient can have a repeat of steroid if no prolonged relief and good relief with local anesthetic.

Manufacturer Narrative

Patient codes have been updated based on the information received on september 27, 2022.Block b3 date of event: date of event was approximated to july 07, 2018, the date symptoms were first noted, 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) elliot health system, manchester, new hampshire block h6: patient codes e1405, e2333, e232401, e1901, e2330, e0123, e1309, e0126, e1301 and e2326 capture the reportable event of dyspareunia, prolapse, fecal incontinence, bacterial infection, pain and nerve damage, urinary retention, neuropathy, dysuria and inflammation.Impact codes f1903, f2303, f1202 and f23 capture the reportable events of device explantation, medication required, inability to work or perform some daily activities and nerve block.Block 11: blocks b2 and g2 have been corrected.

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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

10711038

MDR Text Key

212291463

Report Number

3005099803-2020-04575

Device Sequence Number

Product Code

OTN

UDI-Device Identifier

08714729839279

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

12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Expiration Date

12/05/2020

Device Model Number

M0068505110

Device Catalogue Number

850-511

Device Lot Number

0021479348

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Initial Date Manufacturer Received

09/23/2020

Initial Date FDA Received

10/21/2020

Supplement Dates Manufacturer Received

12/11/2020
01/14/2022
02/27/2022
09/27/2022
11/08/2022
12/06/2022

Supplement Dates FDA Received

01/05/2021
02/11/2022
03/25/2022
10/20/2022
12/08/2022
12/09/2022

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Date Device Manufactured

12/06/2017

Is the Device Single Use?

Yes

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Other; Required Intervention;

Patient Age

53 YR

Patient Sex

Female

Patient Weight

70 KG

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

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