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

Catalog Number 720093-01

Device Problem Insufficient Information (3190)

Patient Problems Anoxia (1711); Aspiration/Inhalation (1725); Cardiac Arrest (1762); Death (1802); Emotional Changes (1831); Encephalopathy (1833); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Prolapse (2475)

Event Date 07/20/2011

Event Type  Death  

Manufacturer Narrative

This was initially reported on the summary report dated august 30, 2014 under (b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced infection, urinary problems, emotional distress, pain, recurrence and a product problem.The plaintiff also experienced leakage, nocturia, other specified genital prolapse and urge incontinence.Furthermore, it was reported that the plaintiff died.The causes of death reported were cardiorespiratory arrest, hypoxic anoxic encephalopathy, cardiopulmonary resuscitation, and aspiration.Related to mfr # 2183959-2016-00033, 2183959-2016-00034.

• Brand Name: AMS ELEVATE ANTERIOR 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: 5367636
• MDR Text Key: 35988553
• Report Number: 2183959-2016-00032
• 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: 07/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/12/2014
• Device Catalogue Number: 720093-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2011
• 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: ELEVATE POSTERIOR
• Patient Outcome(s): Death
• Patient Age: 88 YR
• Patient Weight: 68