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	Erosion (1750); Unspecified Infection (1930); Pain (1994); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503)
Date of Event	11/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of november 21, 2017, 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.The implanting physician is: (b)(6).The explanting physician is: (b)(6).Block h6: the following imdrf patient codes capture the reportable events of: e2330 - pain.E2006 - mesh erosion.E1906 - infection.The following imdrf impact codes capture the reportable events of: f1905 - vaginal mesh removal.F1202 - disability.
Event or Problem Description
It was reported that the patient was implanted with a lynx system device, and she claimed to have experienced extreme pain, infection of her internal bodily tissue, urinary problems, and other injuries as a result of the implantation.Furthermore, the patient claims to have suffered significant mental and physical pain and suffering and has sustained permanent injury.On (b)(6) 2024, the patient was diagnosed with a renal stone and bladder mesh erosion.She underwent right ureteroscopic stone extraction using laser and basket, along with vaginal excision of the mesh.Operative findings included a 1.4 cm renal pelvic stone, which was successfully removed.The stent and vaginal mesh were also removed.However, cystoscopy revealed a remaining portion of mesh within the bladder.On (b)(6) 2025, the patient was diagnosed with a right renal stone, bladder stone, and recurrent bladder mesh erosion.She underwent right ureteroscopic stone extraction, cystolitholapaxy, robotic bladder mesh removal, and right burch urethropexy.Operative findings included renal stones that were lasered and extracted, bladder stones treated with laser, and excision of mesh erosions.A bilateral burch urethropexy was performed.A 200-micron holmium laser fiber was used to remove small stones surrounding both sides of the mesh erosion.

• 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: 22215809
• Report Number: 2124215-2025-38967
• Device Sequence Number: 20997517
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: (01)08714729718949(17)200823(10)21051735
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2025

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: 08/23/2020
• Device Model Number: M0068503000
• Device Catalogue Number: M0068503000
• Device Lot Number: 0021051735
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/16/2025
• Date Device Manufactured: 08/24/2017
• 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; Disability
• Patient Age: 72 YR
• Patient Sex: Female