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); Cardiac Arrest (1762); Death (1802); Sepsis (2067); Urinary Tract Infection (2120); Brain Injury (2219); Injury (2348)

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced an unspecified injury and a product problem.Furthermore, it was reported that the plaintiff died.The causes of death were reported as anoxic brain injury secondary to cardiac arrest and sepsis secondary to urinary tract infection.(b)(4).

Manufacturer Narrative

Updated information.

Event Description

Related to manufacturer report #: 2183959-2016-00020, 2183959-2016-00021, 2183959-2016-00022, and 2183959-2016-00018.

• 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: 5361211
• MDR Text Key: 35703449
• Report Number: 2183959-2016-00019
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• 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,Followup
• Report Date: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/06/2014
• Device Catalogue Number: 720093-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2011
• 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: MINIARC
• Patient Outcome(s): Death
• Patient Weight: 75