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 Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Discomfort (2330); Dysuria (2684); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 06/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).The complainant indicated that the device is implanted and 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

Note: this manufacturer report pertains to one of two devices used during the same procedure.It was reported to boston scientific corporation that the patient was diagnosed with stress urinary incontinence and cystocele.On (b)(6) 2017, she was implanted with uphold (tm) lite with capio slim and lynx suprapubic mid-urethral sling system during a pubovaginal sling, anterior repair, and cystoscopy procedure.On (b)(6) 2017, the patient underwent excision of vaginal mesh procedure due to multiple urinary tract infections, urinary retention, difficulty urinating, painful voiding, bladder spasm, and incomplete bladder emptying.Additionally, extensive scarring was also noticed from previous vaginal surgery.On (b)(6) 2017, the patient underwent total anterior compartment mesh removal and cystoscopy with ureteral catheter placement due to chronic pelvic pain and complications related to vaginal mesh insertion.On (b)(6) 2018, the patient underwent robotic/laparoscopic pre-vesical excision of pelvic mesh due to a retained pelvic mesh, pelvic pain, and dyspareunia.During the procedure, bilateral retropubic mesh arms were visualized and extracted.A cystoscopy procedure was performed and showed no injury to the vaginal lateral or nervous structure.

• 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): 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: 11408966
• MDR Text Key: 234620545
• Report Number: 3005099803-2021-00864
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2020
• Device Model Number: M0068503000
• Device Catalogue Number: 850-300
• Device Lot Number: 0000051888
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR