MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE; SURGICAL MESH

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 09/11/2014

Event Type  Injury  

Event Description

It was reported the patient had an elevate anterior and apical graft implanted in 2011.The patient experienced "pain from tension band at apex." the "band was severed to release the tension" on (b)(6) 2014.No further patient complications were reported in relation to this event.

• Brand Name: AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
• 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: 4128005
• MDR Text Key: 4794370
• Report Number: 2183959-2014-00436
• Device Sequence Number: 1
• Product Code: OTP
• 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: 09/11/2014

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2014
• Initial Date FDA Received: 09/30/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 58 YR