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	Pain (1994); Dyspareunia (4505)
Date of Event	07/08/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block g2: mhra adverse incident report reference no (b)(4); although the country of event is australia, the event was submitted to mhra (medicines and healthcare products regulatory agency) by the physician.Block h6: imdrf patient code e1405 captures the reportable event of dyspareunia.Imdrf patient code e2330 captures the reportable event of pain.
Event or Problem Description
It was reported to boston scientific corporation that an advantage system mesh was implanted into the patient on (b)(6) 2014.After implantation, the patient developed pain requiring medications to treat persistent pelvic pain.It was also reported that the patient has dyspareunia.

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18387797
• Report Number: 2124215-2023-71509
• Device Sequence Number: 19522862
• Product Code: OTN
• UDI-Device Identifier: 08714729470274
• UDI-Public: 08714729470274
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2023

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: 05/31/2017
• Device Model Number: M0068502000
• Device Catalogue Number: 850-200
• Device Lot Number: ML00002351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2014
• 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: 55 YR
• Patient Sex: Female