MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Lynx? System; mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retr

Model Number	M0068503000
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Erosion (1750); Nerve Damage (1979); Pain (1994); Deformity/ Disfigurement (2360); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Tissue Injury (4559)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that lynx suprapubic mid-urethral sling system was implanted into the patient during a procedure performed on (b)(6) 2024.The device subsequently malfunctioned and eroded into her bladder, resulting in substantial pain, nerve damage, tissue damage, and the need for ongoing medical care, including multiple corrective surgeries, such as removal of the mesh beginning on (b)(6) 2024.Following the procedure, the patient also experienced the following: emotional distress, physical disfigurement, and permanent injury.
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of april 24, 2024, was chosen as a best estimate based on the date of mesh implant.Block e1: this event was reported by the patient's legal representation.Block h6: the following imdrf patient code capture the reportable event of: e2330 - pain.E2006 - erosion.E0206 - mental anguish.E2308 - disfigurement.The following imdrf impact code capture the reportable event of: f1204 - permanent impairment.F1905 - device revision or replacement.

• Brand Name: Lynx? System
• Common Device Name: 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50507215
• Report Number: 2124215-2026-46257
• Device Sequence Number: 9404980
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: (01)08714729718949(17)261204(10)32993824
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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
• Operator of Device: Health Professional
• Device Model Number: M0068503000
• Device Catalogue Number: M0068503000
• Device Lot Number: 0032993824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 12/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Sex: Unknown