MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS ELEVATE (NOT SPECIFIED); SURGICAL MESH

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 07/14/2014

Event Type  Injury  

Event Description

It was reported that following an elevate anterior implantation the patient complained of dyspareunia.A revision surgery was performed, the surgeon dissected the anterior vaginal wall and discovered that the locking eyelet on the patient left side was sitting toward the vagina cuff which she removed.Additional information received indicated that the patient "feels great" and "the pain that she was experiencing is gone." no additional patient complications have been reported in relation to this event.

Manufacturer Narrative

(b)(4).

• Brand Name: AMS ELEVATE (NOT SPECIFIED)
• 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: 3977731
• MDR Text Key: 4889942
• Report Number: 2183959-2014-00345
• 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: 07/14/2014

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: 07/14/2014
• Initial Date FDA Received: 08/04/2014
• 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