MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS ADVANCE XP SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE

Model Number	720163-01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Micturition Urgency (1871); Pain (1994); Discomfort (2330); Skin Inflammation/ Irritation (4545); Urinary Incontinence (4572)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient complained of discomfort, pain, and a burning sensation with the advance xp sling.The physician indicated he felt the sling was causing irritation to the urethra and the patient was still leaking with urgency to urinate.The physician revised the sling by cutting the lateral ends and releasing the sling.An artificial urinary sphincter was also implanted.The patient was expected to fully recover following the revision surgery.

• Brand Name: AMS ADVANCE XP SLING SYSTEM
• Common Device Name: MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 11391800
• Report Number: 2183959-2021-00708
• Device Sequence Number: 3286738
• Product Code: OTM
• UDI-Device Identifier: 00878953005560
• UDI-Public: 00878953005560
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/19/2020
• Device Model Number: 720163-01
• Device Catalogue Number: 720163-01
• Device Lot Number: 0024809723
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 03/01/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR