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

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

Patient Problems Unspecified Infection (1930); Itching Sensation (1943); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Urinary Frequency (2275); Discomfort (2330); Dysuria (2684); Skin Inflammation/ Irritation (4545); Urinary Incontinence (4572)

Event Date 06/17/2013

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a lynx system was implanted during a suprapubic sling insertion procedure performed on (b)(6), 2013 to treat urinary incontinence.On (b)(6) 2013, the patient was experiencing vaginal discomfort, abnormal discharge, inflamed feeling, scratched in sleep, and dysuria.The patient also reported frequent vaginal thrush.The patient was prescribed with clotrimazole 2% cream, applied three times a day 20grams, fluconazole 150mg, 1 capsule taken as a single dose.The patient also underwent a urine dip.On an unknown date, the patient's thrush symptoms persisted with itching and thick white discharge.A mucus discharge was also noted.The patient was swabbed, and she still felt unable to return to work.On (b)(6) 2013, the patient was seen and examined post suprapubic sling operation.It was noted that the patient had an improvement in emptying the bladder and there was no dysuria noted.The patient was also aware of the smell.On (b)(6) 2013, a high vaginal swab taken; however, they were unable to use a speculum as advised against anything being put into vagina for 12 weeks.The patient took the swab herself and msu was sent for culture and sensitivity test.On (b)(6) 2013, the patient's routine genital culture was abnormal.On (b)(6) 2013, the patient was experiencing post operative pain.The patient reported that she was aching and the pain made her unable to drive far.In the physician's assessment, the patient was certainly not able to go back to work 10 hours shifts as theatre nurse.She was going to see an occupational health therapist within 2 weeks to discuss phased return to work.In addition, the patient still experienced urinary leakage and she though the operation has not worked.She was due to see gynae again in 6 weeks.On (b)(6) 2013, the patient was given a second lot of zapain.On (b)(6) 2013, the patient was seen and examined for a suprapubic sling operation review.On (b)(6) 2013, the patient was referred to a urologist.On (b)(6) 2014, the patient was experiencing a low abdominal pain, dysuria and frequency since the night before.Video urodynamics test was undertaken the previous day.The patient had no fever nor loin pain.Upon examination, the patient's urinalysis was abnormal with positive leukocytes and positive protein indicating a urinary tract infection (uti).The patient was prescribed with trimethroprim 200mg, one tablet to be taken twice a day.On (b)(6) 2014, the patient was seen and examined for a suprapubic sling operation review.On (b)(6) 2017, the patient had an operation the previous day for a suburethral sling insertion with trans obturator vaginal tape and cystoscopy.The patient was taking co-codamol and ibuprofen but was still in pain.The patient was prescribed tramadol 50mg one or two capsules to be taken every four hours when necessary.Maximum 8 tablets in 24 hours 30 capsules.On (b)(6) 2018, the patient was seen and examined for sore groin and pubic area.The patient also reported some discharge and itch.Upon examination the patient had folliculitis and some inflamed superficial infected areas with contact bleeding.Also, a whitish discharge and some fungal napkin dermatitis appearances were noted.The patient was prescribed with clotrimazole 500mg pessaries one to be inserted at night, dermol 200 shower emollient, to be applied to skin or used as a soap, substitute 200ml, flucloxacillin 500mg capsules, one to be taken four times a day.They also discussed tramadol and zapain use.Started latter for back pain some years ago, tramadol more recently for groin pain due to mesh, etc.She was surprised by the physician's suggestion she might be addicted and happy to try to reduce note last 1/12 use has reduced she thought possibly weight loss has helped her back pain.They agreed to reduce tramadol to 4 daily maximum for 2/52 then aim to reduce again, and leave zapain as is for now.On (b)(6) 2018, the patient was seen and examined for a pre-operative procedure.On (b)(6) 2018, the patient was issued a not fit to work due to a bladder surgery for a duration of june 12, 2018 until july 31, 2018.On (b)(6) 2018, the patient was seen and examined.She was systematically well but her wound was oozy at either end- swab taken and her abdomen was also red and inflamed in skin fold just beneath wound which looked like a fungal infection.The patient was prescribed with clotrimazole 1% cream apply twice a day 20gram.On (b)(6), 2018, the patient underwent a clinical chemistry/haematology, microbiology and urine bacteriology (msu) test.On (b)(6), 2018, the patient's serum c result was reactive.Her protein level taken on (b)(6), 2018 for culture and sensitivity test was normal.On (b)(6), 2018, the patient's urine culture taken last (b)(6) 2018 yielded normal results.On an unknown date, the patient underwent a removal of repair material from skin 1/52 post operation.The steristrips were removed moist and the wound was noted to be red on both ends of the thrush which increased below sb.The patient was referred for further week of abs change to fluclox and xanestan for fungal infection.The swab was sent to the laboratory.On (b)(6) 2018, the patient was experiencing hot flushes and was feeling groggy again like pre-op.It was noted that she has lots of scar infection and the previous mesh was infected.The patient also has uti.The patient reported that she felt well on abs but the flashes were back.The patient also has premature menopause with her last period on may2018.Upon examination the patient has tender lower abdominal scar and drain site dealt apyrexial.On (b)(6) 2019, the patient presented for examination.The patient had undergone an autologous fascial sling (abdominal/vaginal), partial removal of transobturator tape (tot) and bladder procedure in june 2018.After the surgery, she was still suffering with urine leakage - urgency, stress and passive.The patient needed about 3 to 4 pads over 24 hours.It was noted that the more active the patient was at work, the more she experienced leaking.The patient also had chronic back ache with no neurological symptoms.Per the physician, the patient's plan was reduce weight because the leakage in minimal, refer for pelvic floor exercise, and follow up with urologist in six months.The patient does wish to have anymore major surgency for her urinary stress incontinence.

Manufacturer Narrative

Date of event was approximated to (b)(6) 2013, implant date, as no event date was reported.The complainant was unable to provide the upn and lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).

• 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: 15895145
• MDR Text Key: 304684268
• Report Number: 3005099803-2022-07109
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 38 YR
• Patient Sex: Female