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

Catalog Number 551727023

Device Problem Insufficient Information (3190)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Pain (1994); Scarring (2061); Sepsis (2067); Urinary Frequency (2275); Prolapse (2475); Patient Problem/Medical Problem (2688)

Event Date 10/13/2009

Event Type  Death  

Manufacturer Narrative

Lawyer-filed report.

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced cystocele, vault prolapse, stress and urge urinary incontinence, frequency with urination, urethrocele, leakage, urgency and urinary tract infection.It was also reported that the plaintiff experienced pain, recurrence, dyspareunia, vaginal scarring and contraction.It was reported that the plaintiff underwent a revision surgery.The device was partially explanted.Furthermore, it was reported that the plaintiff died.The cause of death reported was sepsis secondary to infarction.Related to manufacturer report #: 2183959-2014-38550, related to manufacturer report #: 2183959-2014-38552, related to manufacturer report #: 2183959-2014-51553.

• Brand Name: AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren rd w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren rd w; minnetonka MN 55343
• Manufacturer Contact: erika merrick ; 10700 bren rd w; minnetonka, MN 55343 ; 8442511068
• MDR Report Key: 5047517
• MDR Text Key: 24754779
• Report Number: 2183959-2015-58803
• 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: consumer,other
• Reporter Occupation: Attorney
• Report Date: 12/11/2013

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: 06/12/2009
• Device Catalogue Number: 551727023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2008
• 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
• Patient Age: 70 YR
• Patient Weight: 68