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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Deformity/ Disfigurement (2360); Unspecified Mental, Emotional or Behavioural Problem (4430)
Date of Event	12/07/2022
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) 2022, for the treatment of stress urinary incontinence.On or about (b)(6) 2025, the patient consulted to a specialist after several years of complications and pain related to her pelvic mesh.The patient then underwent procedure for revision and removal of the mesh.Following the procedure, the patient experienced significant mental and physical pain and suffering, sustained permanent injury and substantial physical deformity, underwent medical treatment, and will likely require corrective surgery or additional surgeries.
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6)2022 was chosen as a best estimate based on the date of the mesh was implanted.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 d4 unique identifier (udi) #: detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block e1: this event was reported by the patient's legal representation.Block h6: the following imdrf patient code captures the reportable event of: e2330 - captures the reportable event of pelvic pain.E0206 - captures the reportable event of mental anguish.E2308 - captures the reportable event of physical disfigurement.The following imdrf impact code captures the reportable events of: f1905 - captures the reportable event of mesh removal.F1204 - captures the reportable event permanent impairment.

• 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; saiint paul, MN 55112
• MDR Report Key: 50526939
• Report Number: 2124215-2026-46538
• Device Sequence Number: 15930361
• Product Code: OTN
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 08/31/2026
• 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: Disability; Required Intervention
• Patient Sex: Unknown