MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Model Number	M0068507000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2018, was chosen as a best estimate based on the date of mesh implant.The implanting physician is: (b)(6).Block h6: imdrf patient code e2401 captures the reportable event of unspecified injury related to mesh.Imdrf impact code f12 has been used in the light of the patient had filed a legal claim for an unspecified personal injury related to the mesh.
Event or Problem Description
It was reported to boston scientific corporation that a solyx sis system was implanted into the patient during a procedure performed on (b)(6) 2018.As reported by the patient's attorney, the patient has experienced an unspecified injury.Additional details regarding this event were not provided.

• Brand Name: SOLYX SIS SYSTEM
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• 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: 24259768
• Report Number: 2124215-2026-06417
• Device Sequence Number: 13174018
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: (01)08714729774044(17)201205(10)21476320
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K081275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 02/04/2026

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
• Device Expiration Date: 12/05/2020
• Device Model Number: M0068507000
• Device Catalogue Number: M0068507000
• Device Lot Number: 0021476320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/04/2026
• Date Device Manufactured: 12/06/2017
• 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: Other
• Patient Age: 61 YR
• Patient Sex: Female