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

Model Number	M0068502000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Muscle Weakness/Atrophy (1967); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Deformity/ Disfigurement (2360); Urinary Incontinence (4572); Insufficient Information (4580)
Date of Event	06/01/2023
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) 2023, 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 implanting and explanting surgeon is: dr (b)(6).(b)(6) hospital (b)(6).Block h6: the imdrf patient codes capture the reportable events of: e0123: captures the reportable event of femoral nerve damage.E0126: captures the reportable event of left femoral neuropathy.E2330: captures the reportable event of leg pain, left groin pain, and lower back pain.E1621: captures the reportable event of left lower extremity weakness.E0506: captures the reportable event of vaginal bleeding.E2401: captures the reportable event of pelvic floor dysfunction.E2308: captures the reportable event of disfigurement.The imdrf impact code capture the reportable event of: f1202: captures the reportable event of mobility impairments and left-sided limp.F1905: captures the reportable event of partial device excision.
Event or Problem Description
It was reported that the patient had an advantage fit system implanted during a procedure and has since experienced complications, including femoral nerve damage, left femoral neuropathy, mobility impairments, ongoing leg pain, left groin pain, lower back pain, pelvic floor dysfunction, left lower extremity weakness, urge urinary incontinence, stress urinary incontinence, and vaginal bleeding.Furthermore, the patient developed a left-sided limp.As a result, the patient underwent a partial mesh removal surgery.The patient suffered significant pain, unnecessary expense, embarrassment, disfigurement, and harm due to the implanted device.Additionally, the patient claims that she may have to undergo additional surgery and may suffer future damages such as significant pain, severe and debilitating injuries, serious bodily injury, mental and physical pain and suffering, and medical expenses due to the implantation of the device.

• Brand Name: ADVANTAGE? 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: 21938336
• Report Number: 2124215-2025-26172
• Device Sequence Number: 5343471
• Product Code: OTN
• UDI-Device Identifier: 08714729470274
• UDI-Public: (01)08714729470274(17)260405(10)31380534
• 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: 2023
• 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): 04/30/2025

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: 04/05/2026
• Device Model Number: M0068502000
• Device Catalogue Number: M0068502000
• Device Lot Number: 0031380534
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 04/30/2025
• Date Device Manufactured: 04/06/2023
• 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
• Patient Sex: Female