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

Catalog Number 720127-01

Device Problem Insufficient Information (3190)

Patient Problems Congestive Heart Failure (1783); Death (1802); Emotional Changes (1831); Pain (1994); Injury (2348); Deformity/ Disfigurement (2360)

Event Type  Death  

Manufacturer Narrative

This was initially submitted on the summary report dated december 23, 2014 under (b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced a physical injuries and damages, pain, suffering, mental anguish, emotional distress, physical impairment, disfigurement, other serious injury and a product problem.Furthermore, it was reported that the plaintiff died.The causes of death reported were congestive heart failure and mild renal insufficiency.Related to mfr # 2183959-2015-00602.

• Brand Name: AMS ELEVATE POSTERIOR 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: erika merrick ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 5332403
• MDR Text Key: 34588487
• Report Number: 2183959-2015-00601
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/08/2013
• Device Catalogue Number: 720127-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2010
• 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: MONARC
• Patient Outcome(s): Death