MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM; SURGICAL MESH

Catalog Number 720127-01

Device Problem Extrusion (2934)

Patient Problems Erosion (1750); Emotional Changes (1831); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Injury (2348); Deformity/ Disfigurement (2360); Disability (2371)

Event Date 11/29/2012

Event Type  Injury  

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced vaginal pain, recurring incontinence, dyspareunia, severe and disabling injuries, mental and physical pain and suffering, mental anguish, physical impairment, physical disfigurement, and infection.It was additionally reported the plaintiff had eroded mesh removed on (b)(6) 2012, (b)(6) 2013.On (b)(6) 2013 the plaintiff was brought in to surgery for mesh erosion into the bladder; however it was noted that just scar tissue was present and there was no erosion of mesh into the bladder.No further complications were reported in relation to the event.

Manufacturer Narrative

Lawyer-filed report (b)(6).

• Brand Name: ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren rd., west; minnetonka MN 55343
• Manufacturer Contact: sharon zurn, director ; 10700 bren rd., west; minnetonka, MN 55343 ; 9529306347
• MDR Report Key: 3613090
• MDR Text Key: 20357948
• Report Number: 2183959-2014-10012
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/22/2014

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
• Device Expiration Date: 10/06/2014
• Device Catalogue Number: 720127-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2014
• Initial Date FDA Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IMPLANT:; MINIARC PRECISE; ELEVATE ANTERIOR; IMPLANT:
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 49 YR