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); Pain (1994); Urinary Tract Infection (2120)
Date of Event	03/26/2019
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 (b)(6) 2019, was chosen as a best estimate based on the date of the mesh was implanted.This event was reported by the patient's legal representation.The implant and explant surgeon is: dr.(b)(6).Block h6: e1310 - captures the reportable event of urinary tract infections f1905 - captures the reportable event of mesh excision.
Event or Problem Description
It was reported that after the patient had been implanted with a lynx system device, she experienced recurrent urinary tract infections.She subsequently underwent periurethral removal of the mesh.During the procedure, a cystoscope was placed to identify the periurethral mesh.The mesh was identified, dissected, and trimmed by about 2 cm.Tissue was sent for pathology.The dead space around the urethra was closed with 3-0 vicryl, and the skin was closed with 2-0 vicryl.Floseal was used for hemostasis.Cystoscopy showed intact urothelium.The patient tolerated the procedure well and remained hemodynamically stable.
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of march 26, 2019, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implant and explant surgeon is: dr.(b)(6).(b)(6) medical center.(b)(6).Block h6: e1310 - captures the reportable event of urinary tract infections.E2006 - captures the reportable event of mesh exposure and erosion.F1905 - captures the reportable event of mesh excision.Block b5 has been updated.
Event or Problem Description
It was reported that after the patient had been implanted with a lynx system device, she experienced pain, mesh exposure and erosion, and recurrent urinary tract infections.She subsequently underwent periurethral removal of the mesh.During the procedure, a cystoscope was placed to identify the periurethral mesh.The mesh was identified, dissected, and trimmed by about 2 cm.Tissue was sent for pathology.The dead space around the urethra was closed with 3-0 vicryl, and the skin was closed with 2-0 vicryl.Floseal was used for hemostasis.Cystoscopy showed intact urothelium.The patient tolerated the procedure well and remained hemodynamically stable.

• 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: 20695742
• Report Number: 2124215-2024-70982
• Device Sequence Number: 3756904
• Product Code: OTN
• UDI-Device Identifier: 08714729718949
• UDI-Public: 08714729718949
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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: 07/31/2021
• Device Model Number: M0068503000
• Device Catalogue Number: 850-300
• Device Lot Number: 0022454144
• 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: 10/17/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/11/2024
• Date Device Manufactured: 08/01/2018
• 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: Other; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female