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

Model Number M0068503000

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

Patient Problems Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Erosion (1750); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Scarring (2061); Urinary Retention (2119); Urinary Tract Infection (2120); Chills (2191); Urinary Frequency (2275); Injury (2348); Dysuria (2684); No Code Available (3191); Insufficient Information (4580)

Event Date 08/01/2015

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2014, implant date, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(6).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 a lynx suprapubic mid-urethral sling device was implanted into the patient during a procedure performed on (b)(6) 2014.As reported by the patient's attorney, after the implantation, the patient has experienced abdominal and pelvic pain, dyspareunia, erosion, infections, urinary problems, vaginal scarring, urethral damage and reconstruction.Boston scientific has been unable to obtain additional information regarding the event to date.

Event Description

It was reported to boston scientific corporation that a lynx suprapubic mid-urethral sling device was implanted into the patient during a lynx bladder suspension procedure performed on (b)(6) 2014 for the treatment of stress incontinence, moderate to severe urge incontinence and mild urge incontinence.Associated symptoms moderate to severe urge incontinence and mild urge incontinence.Associated symptoms included frequency and nocturia.Following the implant procedure, the patient was in retention for approximately 4 weeks.In (b)(6) 2015, the patient started to experience chronic utis and was on and off multiple medications since that time.On (b)(6) 2018, the patient presented complaining of recurrent uti with back pain, splayed stream, dysuria and urinary frequency.During a follow up visit on (b)(6) 2019, the patient complained of chills and recurrent uti.Nitrofurantoin macrosrystal 50mg oral capsule were added to her medication list.On (b)(6) 2019, the patient underwent a cystoscopy procedure for recurrent uti.During the procedure, the patient's bladder was emptied of its contents.The findings were normal bladder mucosa.On (b)(6) 2019, the patient presented to the er for recurrent urinary tract infections and urinary retention.Post-void residual was normal, and urodynamics and renal ultrasound were recommended.A clinical note on (b)(6) 2019 stated that the patient had been taught to self-catheter in the past but was unable to do so because of what she described as a blockage.Additionally, urodynamic study findings of overactive bladder.On (b)(6) 2019, the patient was diagnosed with a urethral diverticulum, confirmed via mri.On (b)(6) 2019, the patient underwent cystoscopy, excision of suburethral sling eroded into the urethra, closure of defect in urethra and diverticula, suprapubic incision with harvesting of rectus fascia, pubovaginal sling with rectus fascia to support the urethral diverticular closure and post procedure cystoscopy.On (b)(6) 2019, the patient had a voiding cystogram following the urethral diverticulum repair.X-rays showed no leakage, and the foley catheter was removed.On (b)(6) 2019 the patient had a post-op visit and reported that the lower abdominal incision had opened up and she noticed inflammation, blood and pus.Physical examination on showed some granulation tissue, urethral incision, granulation tissue removed and silver nitrate applied.Pelvic exam was unremarkable.The assessment was normal postop can return to normal activities next week.

Manufacturer Narrative

Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2015 was chosen as a best estimate based on the information that the onset of chronic utis beginning in (b)(6) 2015.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Tel #: (b)(6), fax #:(b)(6).Sling excision surgeon: (b)(6), phone: (b)(6), fax: (b)(6).Block h6: patient codes e2006, e1309, e1310, e1715, e1301, e2340, e172001, e2330 and e2326 capture the reportable events of erosion, urinary retention, uti, scar tissue, dehiscence, dysuria, abscess, pain and incision became red impact codes f1903, f2301, f1901 and f2303 capture the reportable events of additional surgery, device explantation, addtional sling implanted, and medications.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.The removed mesh is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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
• MDR Report Key: 10704588
• MDR Text Key: 212101885
• Report Number: 3005099803-2020-04545
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: 08714729718949
• Combination Product (y/n): N
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

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 Model Number: M0068503000
• Device Catalogue Number: 850-300
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 09/02/2021
• Supplement Dates FDA Received: 09/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 71