MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Advantage System; mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retr

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Tissue Injury (4559)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that the patient was implanted with an advantage mid-urethral sling system during procedures performed on (b)(6) 2023, and (b)(6) 2024, for the treatment of stress urinary incontinence (sui).The procedures were reportedly completed without intraoperative complications.Following implantation, the patient allegedly experienced significant mental and physical pain and suffering, permanent injury, and permanent and substantial physical deformity.The patient further claims to have undergone, and may require additional, corrective surgery or surgeries.Additionally, the patient alleges financial and economic losses, including loss of income and medical expenses, which are claimed to be associated with the implanted device.The patient alleges that the injuries were caused by defects in the design and/or manufacturing of the product, the cause of which was not reasonably discoverable despite the exercise of due diligence.As a result, the patient alleges significant pain and suffering, permanent injuries, economic damages, and other related harms.
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of september 4, 2024, was chosen as a best estimate based on the date of the mesh was implanted.Blocks d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block d4 unique identifier (udi) #: detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: the following imdrf patient code captures the reportable event of: e0206 - captures the reportable event of mental pain and suffering e2015 - captures the reportable events of physical pain, substantial physical deformity and permanent injury the following imdrf impact code captures the reportable events of: f1202 - captures the reportable event of patient being permanent injured f12 - captures the reportable event of patient being seriously injured.

• 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: 50148827
• Report Number: 2124215-2026-42032
• Device Sequence Number: 10607475
• Product Code: OTN
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 08/05/2026

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
• 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: 07/08/2026
• Initial Report FDA Received Date: 08/05/2026
• 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 Sex: Female