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

Catalog Number 720093-01

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Death (1802); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Urinary Tract Infection (2120); Discharge (2225)

Event Date 09/29/2010

Event Type  Death  

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced vaginal discharge with foul odor, urinary tract infection, infection, inflammatory reaction, vaginitis, genital tract-skin fistula, pelvic peritoneal adhesions and recurrent bleeding abscess.Furthermore, it was reported that the plaintiff died.No cause of death was reported.Related to manufacturer reports: 2183959-2014-71295, 2183959-2014-71301.

Manufacturer Narrative

This was initially reported on the summary report dated 12/23/2014 under exemption (b)(4).Lawyer-filed report.

• Brand Name: AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka MN 55343
• Manufacturer Contact: sharon zurn, director ; 10700 bren road west; minnetonka, MN 55343 ; 9529306347
• MDR Report Key: 4530196
• MDR Text Key: 5518175
• Report Number: 2183959-2014-71298
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• 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: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2013
• Device Catalogue Number: 720093-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2010
• 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
• Treatment: SPARC; ELEVATE POSTERIOR
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Weight: 81