MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS PERIGEE SYSTEM WITH INTEPRO; MESH, SURGICAL, POLYMERIC

Catalog Number 720003-01

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Cardiopulmonary Arrest (1765); Death (1802); Dementia (1808); Emotional Changes (1831); Pain (1994); Urinary Tract Infection (2120); Injury (2348); Deformity/ Disfigurement (2360)

Event Date 02/10/2011

Event Type  Death  

Manufacturer Narrative

(b)(4).Lawyer-filed report.

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced emotional distress, pain and suffering, mental anguish, disfigurement, physical impairment, embarrassment, humiliation, psychological injury, a reasonable and traumatic fear of an increased risk of additional injuries, progression of existing conditions, other serious injury and loss, and a product problem.The plaintiff also experienced recurrent urinary tract infections, nocturia and mesh erosion.Furthermore, it was reported that the plaintiff died.The causes of death reported were cardiorespiratory arrest and end stage dementia.Related to manufacturer report #: 2183959-2014-37035.

• Brand Name: AMS PERIGEE SYSTEM WITH INTEPRO
• 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: 5146837
• MDR Text Key: 28135520
• Report Number: 2183959-2014-37036
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Report Date: 07/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2011
• Device Catalogue Number: 720003-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2008
• 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
• Treatment: MONARC
• Patient Outcome(s): Death
• Patient Age: 87 YR