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

Model Number M0068503000

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

Patient Problems Erosion (1750); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Obstruction/Occlusion (2422); Prolapse (2475); Tissue Breakdown (2681); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Unspecified Tissue Injury (4559)

Event Date 02/06/2019

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a lynx system was implanted during a laparoscopic sacrocolpopexy with non bsc y mesh, cystoscopy, midurethral sling procedure performed on (b)(6) 2019 for treatment of vaginal vault prolapse, rectocele, and stress urinary incontinence.The patient underwent a procedure for mesh removal and pelvic reconstruction on (b)(6) 2019.The patient was diagnosed with pudendal neuralgia in (b)(6) 2022.

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2022, date of neuralgia diagnosis, as no exact event date was reported.Initial reporter name and address: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2022, date of neuralgia diagnosis, as no exact event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: eleanor ray friele, md swedish medical center usa block h6: patient code e2330 captures the reportable event of pain.Patient code e0123 captures the reportable event of nerve damage.Impact code f1905 captures the reportable event of device revision.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Block h11: blocks b5, h6 and h10 have been updated based on the additional information received on january 6, 2023.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: eleanor ray friele, md swedish medical center usa the revision procedure was performed by: (b)(6) md (b)(6) hospital (b)(6) block h6: patient code e2330 captures the reportable event of pain.Patient code e0123 captures the reportable event of nerve damage.Patient code e1405 captures the reportable event of dyspareunia.Patient code e1311 captures the reportable events of voiding dysfunction due to 2 prior mid urethral slings and urethral injury (from 2 tight slings).Patient code e1309 captures the reportable event of incomplete bladder emptying.Patient code e2006 captures the reportable event of mesh "sawed through" urethral muscle.Patient code e1715 captures the reportable event of short tvl- transvaginal length- likely related to multiple prior surgeries.Patient code e2014 captures the reportable event of "paper thin" layer of urethral tissue noted to be from the absence of the urethral muscles at the urethra because they had been attached to the vaginal incision.Impact code f1901 captures the reportable event of urethral reconstruction.Impact code f1905 captures the reportable event of device revision.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

Event Description

It was reported to boston scientific corporation that a lynx system was implanted during a laparoscopic sacrocolpopexy with non bsc y mesh, cystoscopy, midurethral sling procedure performed on (b)(6) 2019 for treatment of vaginal vault prolapse, rectocele, and stress urinary incontinence.The patient underwent a procedure for mesh removal and pelvic reconstruction on october 19, 2019.The patient was diagnosed with pudendal neuralgia in june 2022.***additional information received on january 6, 2023*** additional information received clarifies that the mesh removal and pelvic reconstruction was performed on (b)(6) 2019 and not october 19, 2019 as previously indicated.On (b)(6) 2019, the patient underwent partial sling excision, urethral repair, cystoscopy, posterior colporrhaphy procedures.Preoperative diagnoses were rectocele, incomplete bladder emptying, voiding dysfunction, dyspareunia, and chronic pelvic pain.In the physician's assessment, the pelvic pain was likely related to 2 prior slings or prior uphold vaginal mesh.Following the procedure, the patient was diagnosed with a urethral injury from 2 tight slings.Procedure findings were as follows: 1.Prior lynx sling was located very distal near external meatus instead of the mid-urethra.The sling was on tension and "sawed through" the urethral meatus.2.Prior advantage sling also located near the external meatus, underneath the newer lynx sling.The sling was also on tension and "sawed through" the urethral meatus.A decision was made to remove this sling also as it was 2mm away from a mid-urethral erosion.3.Each sling was identified and incised.Each sling was dissected to remove approximately 2mm of mesh on each side.Cystoscopy confirmed no injury.4.Urethral muscle was injured from tight sling and needed reconstruction.Following excision of the slings, the urethral muscles were not present at the urethra and were instead attached to the vaginal incision and needed to be reconstructed.A paper-thin layer of urethral tissue could be palpated between the physician's finger and the foley.5.Blue mesh fragments consistent with prior uphold mesh.6.Short transvaginal length, 5-6cm, likely related to multiple surgeries.The procedure was completed with no complications.

Event Description

It was reported to boston scientific corporation that a lynx system was implanted during a laparoscopic sacrocolpopexy with non bsc y mesh, cystoscopy, midurethral sling procedure performed on (b)(6) 2019 for treatment of vaginal vault prolapse, rectocele, and stress urinary incontinence.The patient underwent a procedure for mesh removal and pelvic reconstruction on (b)(6) 2019.The patient was diagnosed with pudendal neuralgia in (b)(6) 2022.Additional information received on january 6, 2023.Additional information received clarifies that the mesh removal and pelvic reconstruction was performed on (b)(6) 2019 and not october 19, 2019 as previously indicated.On (b)(6) 2019, the patient underwent partial sling excision, urethral repair, cystoscopy, posterior colporrhaphy procedures.Preoperative diagnoses were rectocele, incomplete bladder emptying, voiding dysfunction, dyspareunia, and chronic pelvic pain.In the physician's assessment, the pelvic pain was likely related to 2 prior slings or prior uphold vaginal mesh.Following the procedure, the patient was diagnosed with a urethral injury from 2 tight slings.Procedure findings were as follows: 1.Prior lynx sling was located very distal near external meatus instead of the mid-urethra.The sling was on tension and "sawed through" the urethral meatus.2.Prior advantage sling also located near the external meatus, underneath the newer lynx sling.The sling was also on tension and "sawed through" the urethral meatus.A decision was made to remove this sling also as it was 2mm away from a mid-urethral erosion.3.Each sling was identified and incised.Each sling was dissected to remove approximately 2mm of mesh on each side.Cystoscopy confirmed no injury.4.Urethral muscle was injured from tight sling and needed reconstruction.Following excision of the slings, the urethral muscles were not present at the urethra and were instead attached to the vaginal incision and needed to be reconstructed.A paper-thin layer of urethral tissue could be palpated between the physician's finger and the foley.5.Blue mesh fragments consistent with prior uphold mesh.6.Short transvaginal length, 5-6cm, likely related to multiple surgeries.The procedure was completed with no complications.Additional information received on july 19, 2023.On (b)(6) 2019, the patient underwent a laparoscopic sacrocolpopexy, cystoscopy, and mid-urethral sling with permanent mesh placement.On (b)(6) 2019, the patient reported incomplete bladder emptying occasionally, but empties after a second attempt.She reports abdominal soreness with prolonged standing or sitting.As of (b)(6) 2019, the patient has reported tolerating her pain well and has experienced no difficulty with voiding or urinary incontinence.Bowel movements are soft daily.She had minimal cramping with initial penetration and no vaginal pain at rest.She was noted to have decreased stream and stress urinary incontinence with a full bladder.She was happy with the outcome so far.On (b)(6) 2019, the patient returned to work and experienced vaginal pain inside and near the opening when walking.She was also in pain throughout intercourse.There was no dysuria.She denies having stress incontinence of urine.Bowel movement feels incomplete, and she notices a vaginal bulge again.The doctor prescribed vaginal estrogen to the patient, and they also discussed surgically reducing the tension on the y-mesh.This will be done if her pain persists for more than two months.On (b)(6) 2019, the patient visited the clinic for a follow-up on prolapse and pelvic pain.Since her last visit, she has tried vaginal estrogen, which did not help.She also had constant lower back and lower abdominal pain, going from a 7 out of 10 pain score to a 3 out of 10 with motrin, which she takes daily at work.Reportedly, she was unable to have sex.She has pain with valsalva for voiding.Valsalva voiding is not new, but the pain associated with it is.She denies stress urinary incontinence with coughing, as she did before the sling procedure, but notes that her underwear always feels damp.On (b)(6) 2019, the patient presented for evaluation of urinary incontinence, pelvic pain, and pelvic organ prolapse.Assessment and plan: urinary incontinence/overactive bladder since the surgery in 2019, the urinary incontinence leaking is worse, and no obvious sui trigger.Voids every hour of a day; she also has urge urinary incontinence and leaking seems random to her.Main ui triggers are walking, no leaking felt, knows it is wet when she goes to void.Uses 3-4 medium pads during the day, and at night.They will do a trial of ditropan.Pelvic pain: since the vaginal uphold mesh removal surgery in 2018, the pelvic pain went from a 7 to a 3 out of 10.Since the mesh insertion and pop repair, she has had pain daily, constant.Pain is described as a dull ache in the lower abdomen, pelvis, and low back, not burning or sharp.She points to the lower back/buttock, bilateral, not at the top of the sacrum where the mesh was.She uses motrin 800 mg twice at work, which helps with pain.She has not used tylenol or gabapentin, or elavil; the physician has recommended trying these before repeat surgery.Pelvic organ prolapse: she has a vaginal bulge, desires repair, pelvic organ prolapse signs of bulge, pressure, heaviness, bowel movement strain, and incomplete bladder emptying.The patient presented to the clinic on (b)(6) 2019, for evaluation of pelvic organ prolapse, urinary incontinence, and pain.The patient complains of a bothersome recurring vaginal bulge.She experiences a "baby crowning" sensation, her urinary stream is sprayed, she has to strain for bowel movement, and she denies splinting for voiding or bowel movement.She claims that sex is painful.She also feels pain in her groin, lower belly, and back merely sitting and walking.She claimed that the pain is a 3 out of 10, with a maximum of a 6 out of 10.She claims it frequently reaches 6 out of 10 because she walks a lot for work.Assessment: likely due to too much tension on sacrocolpopexy mesh.Rectocele.Plan: magnetic resonance imaging (mri) lumbar spine to evaluate for discitis or osteitis.If magnetic resonance imaging (mri) is normal, the physician will plan for laparoscopic mesh revision, cystoscopy, and posterior colporrhaphy.Review of systems: abdomen: soft, no mass, non-distended, no hernia, bmi 44 non-tender, except for right lower quadrant tenderness, possibly over the lapsc mesh implant.Vagina: no lesions, no discharge, no atrophy, non-tender.There was some tender scarring near the apex and a tender nodule, about 5 mm.No mesh erosion.There is no obvious tender location from the prior uphold mesh (per her report, there is still some mesh on the left apex).The lapsc/non-boston scientific mesh does not appear too tight, has some mild tenderness but "sags" mildly, and does not appear to be tight at all.On n(b)(6) 2019, the patient reported that she voids better.She hadn't had sex yet, but there was no pelvic pain at rest, and on the exam, only mid discomfort was felt, so likely the dyspareunia improved significantly.She no longer has symptoms of urinary incontinence.The patient presented to the clinic on (b)(6) 2019, for a postoperative visit.She reported voiding more frequently.She hadn't had sex yet, but there was no pelvic pain at rest or mild discomfort on the exam, indicating that the dyspareunia had likely improved significantly.She no longer has urine incontinence symptoms.On (b)(6) 2020, the patient visited the clinic and believed she had prolapsed again.Below are patient's diagnosis during her visit: overactive bladder; dyspareunia; vaginal vault prolapse; cystocele.

Manufacturer Narrative

Block h2: additional information blocks b5 (event description), e1 (initial reporter), and h6 (patient and impact codes) has been updated based on the additional information received on july 19, 2023.Correction: block b3 (date of event) has been updated.Block b3 date of event: date of event was approximated to (b)(6) 2019, date of implant, as no exact event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The revision procedure was performed by: (b)(6).Block h6: the following imdrf patient codes capture the reportable events below: patient code e2330 captures the reportable event of pain.Patient code e0123 captures the reportable event of nerve damage.Patient code e1405 captures the reportable event of dyspareunia.Patient code e1311 captures the reportable events of voiding dysfunction due to 2 prior mid urethral slings and urethral injury (from 2 tight slings).Patient code e1309 captures the reportable event of incomplete bladder emptying.Patient code e2006 captures the reportable event of mesh "sawed through" urethral muscle.Patient code e1715 captures the reportable event of short tvl- transvaginal length- likely related to multiple prior surgeries.Patient code e2014 captures the reportable event of "paper thin" layer of urethral tissue noted to be from the absence of the urethral muscles at the urethra because they had been attached to the vaginal incision.Patient code e2328 capture the reportable event of bowel movement incomplete and bowel movement straining.The following imdrf impact codes capture the reportable events below: impact code f1901 captures the reportable event of urethral reconstruction.Impact code f1905 captures the reportable event of device revision.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Impact code f2303 captures the reportable event of patient was given a vaginal estrogen and motrin prescription.

• Brand Name: LYNX SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15986853
• MDR Text Key: 305509205
• Report Number: 3005099803-2022-07378
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: 08714729718949
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2021
• Device Model Number: M0068503000
• Device Catalogue Number: 850-300
• Device Lot Number: 0022759888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 01/06/2023; 07/19/2023
• Supplement Dates FDA Received: 01/26/2023; 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 93 KG