MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC.; PROSTHESIS, URETHRAL SPHINCTER

Model Number 720066-01

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Incontinence (1928)

Event Date 11/19/2015

Event Type  malfunction  

Event Description

Patient reports significant urinary incontinence after implantation of urinary sphincter and cuffs.These devices were removed and replaced nineteen months later.

• Type of Device: PROSTHESIS, URETHRAL SPHINCTER
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka, MN 55343
• MDR Report Key: 5379283
• MDR Text Key: 36423736
• Report Number: 5379283
• Device Sequence Number: 1
• Product Code: FAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/08/2019
• Device Model Number: 720066-01
• Device Lot Number: 868990005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 107