MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS ADVANCE MALE SLING SYSTEM; MESH, SURGICAL, FOR STRESS URINARY INCONTINENCE, MALE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Incontinence (1928)

Event Type  Injury  

Event Description

It was reported that the patient experienced recurring incontinence following the implant of the advance male sling system.The patient believes the insertion of the sling was highly successful and noticed that his penis "was slightly pulled back from it's usual position." immediately following the implant procedure, the patient was completely continent, had no problem urinating, and was able to discontinue the use of pads.After about four months the patient experienced minor leaks, once had a much larger uncontrolled leak when walking, and his "penis was coming out of its pulled back position." by the end of the first year since the advance sling surgery the patient had to resume wearing pads and noticed that his "penis was fully extended." after nearly two years of the sling implant, the patient believes that his sling has "completely failed." the patient has seen his physician and that the physician was assessing whether or not the patient is a candidate for an artificial urinary sphincter implant.No surgery or intervention has been scheduled at this time.No additional patient complications were reported in relation to this event.

• Brand Name: AMS ADVANCE MALE SLING SYSTEM
• Type of Device: MESH, SURGICAL, FOR STRESS URINARY INCONTINENCE, MALE
• 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: 5948715
• MDR Text Key: 54630284
• Report Number: 2183959-2016-00158
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• 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: 08/22/2016

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: 08/22/2016
• Initial Date FDA Received: 09/14/2016
• 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): Required Intervention