MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LYNX BLUE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number	M0068503010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Unspecified Kidney or Urinary Problem (4503)
Date of Event	04/06/2021
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) 2021, was chosen as a best estimate based on the date the device was implanted.Block e1: this event was reported by the patient's legal representation.The implanting and repair surgeon is: dr.(b)(6).The explanting surgeons are: dr.(b)(6).Dr.(b)(6).Block h6: the imdrf patient codes capture the reportable events of: e1310 - captures the reportable event of recurring urinary tract infection e1311 - captures the reportable event of voiding dysfunction the imdrf impact code capture the reportable event of: f1905 - captures the reportable event of sling lysis.
Event or Problem Description
It was reported that the patient had a lynx blue system implanted during a procedure for the treatment of cystocele, vaginal vault prolapse, urge and stress incontinence, urinary incontinence due to urethral sphincter incompetence, paravaginal defect and obstructed voiding pattern.The implant procedure was performed without intraoperative complications.Postoperatively, the patient developed recurrent urinary tract infections and voiding dysfunction.On (b)(6) 2025, a sling lysis and cystourethroscopy were performed.During the procedure, a midline vaginal incision was made at the level of the mid-urethra, where the mesh was identified and carefully dissected from surrounding tissue using blunt and sharp dissection.The sling was released in the midline.Cystoscopy revealed no mesh or foreign material in the bladder, and the bladder urothelium appeared normal.The vaginal epithelium was closed, and the patient was transferred to recovery in stable condition.

• Brand Name: LYNX BLUE 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: 22611991
• Report Number: 2124215-2025-49947
• Device Sequence Number: 17516535
• Product Code: OTN
• UDI-Device Identifier: 08714729961932
• UDI-Public: (01)08714729961932(17)231103(10)26294444
• 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: 2021
• 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): 07/25/2025

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: 11/03/2023
• Device Model Number: M0068503010
• Device Catalogue Number: M0068503010
• Device Lot Number: 0026294444
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/25/2025
• Date Device Manufactured: 11/03/2020
• 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
• Patient Age: 32 YR
• Patient Sex: Female