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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Micturition Urgency (1871); Urinary Retention (2119); Urinary Tract Infection (2120); Unspecified Kidney or Urinary Problem (4503); Urinary Incontinence (4572)
Date of Event	09/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 date of event: date of event was approximated to (b)(6) 2018, implant date, as no event date was reported.Block h6: the following imdrf patient codes capture the reportable events of: e1310 - urinary tract infection; e1309 - urinary retention.The following imdrf impact codes capture the reportable events of: f2303 - medication required for the treatment of urinary tract infection.
Event or Problem Description
It was reported that a lynx system was implanted to the patient on (b)(6) 2018.Sometime after implantation, in 2022, the patient presented with a four-year history of recurrent urinary tract infections requiring repeated antibiotic treatment, with emerging antibiotic resistance, as well as stress urinary incontinence, morning urgency, and incomplete bladder emptying.Urodynamic testing performed in 2022 demonstrated sensory urgency with reduced functional bladder capacity and marginally dysfunctional voiding, without convincing evidence of obstruction.The patient subsequently underwent a 12-week course of percutaneous tibial nerve stimulation but reported minimal perceived benefit.By (b)(6) 2025, the patient's urinary tract infections had resolved; however, her primary ongoing concerns included stress urinary incontinence, postural incontinence, and intermittent urge-related leakage.She has been waiting for further testing.

• 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: 24327043
• Report Number: 2124215-2026-08078
• Device Sequence Number: 21291144
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: (01)08714729718949(17)210506(10)22083600
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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 Expiration Date: 05/06/2021
• Device Model Number: M0068503000
• Device Catalogue Number: M0068503000
• Device Lot Number: 0022083600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/12/2026
• Date Device Manufactured: 05/07/2018
• 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; Other
• Patient Sex: Female