MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM

Catalog Number 720093-01

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Emotional Changes (1831); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Frequency (2275); Injury (2348)

Event Type  Death  

Event Description

It was reported by the plaintiff's atty that the plaintiff allegedly experienced infection, bowel problems, dyspareunia, emotional distress, a product problem, injury, and frequency.Additionally, it was reported that the plaintiff experienced dysuria associated symptoms including general malaise, sensation of incomplete emptying of the bladder, pelvic pain, urinary frequency, ,vaginal atrophy, urethral stricture, lower urinary tract infection and mesh in the vaginal wall which was not extruded.Furthermore, it was reported that the plaintiff died.No cause of death was reported.Related to mfr report # 2183959-2014-40771.

Manufacturer Narrative

This was initially reported on the summary report dated (b)(6) 2014 under exemption (b)(4).Lawyer filed report.

• Brand Name: AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka MN 55343
• Manufacturer Contact: sharon zurn, qual compl ; 10700 bren road west; minnetonka, MN 55343 ; 9529306347
• MDR Report Key: 4377584
• MDR Text Key: 18262430
• Report Number: 2183959-2014-30245
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/01/2013

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: 10/13/2012
• Device Catalogue Number: 720093-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2013
• Initial Date FDA Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2009
• 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): Death