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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Micturition Urgency (1871); Incontinence (1928)

Event Date 06/15/2014

Event Type  Injury  

Event Description

It was reported by the patient that he had an advance sling implanted approximately 8 years ago.Initially it significantly reduced the incontinence going from over 3 pads down to less than 1.His condition is continuing to deteriorate and he is now between 1.5 to 2 pads per day.The patient also reports that he has noticed a deterioration in bladder control.When the urge to urinate develops, his ability to control the urge until he is able to urinate is becoming "less and less." a physician recommended he start taking medication however, he has not taken that advice and contacted his urologist to inquire about available options.No revision surgery scheduled at this time and the patient outcome was reported as "incontinence." no additional patient complications have been reported in relation to this event.

• 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: 3911487
• MDR Text Key: 17277840
• Report Number: 2183959-2014-00271
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2014

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2014
• Initial Date FDA Received: 07/03/2014
• 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