MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS ADVANCE MALE SLING SYSTEM; SURGICAL MESH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Incontinence (1928)

Event Type  Injury  

Event Description

It was reported that the patient had an advance sling implanted.The patient experienced recurring incontinence within 4 weeks of the initial implant.It was reported that "the leakage went from about 30% to 70% and is now not functioning".The patient also alleged that "incontinence changed radically to 100% immediately." prior to the implant surgery, the patient alleged that he had only been using three pads in 24 hours and had some control of his bladder.After surgery, the patient alleged he now has no control of his bladder.The patient stated "since the surgery i have no choice of when to urinate." there were no further patient complications reported as a result of this event.Related to manufacturer report # (b)(4).

• Brand Name: AMS ADVANCE MALE SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 4811552
• MDR Text Key: 5835830
• Report Number: 2183959-2015-00221
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2015

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/05/2015
• Initial Date FDA Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability