MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS MINIARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 720046-01

Device Problem Insufficient Information (3190)

Patient Problems Aneurysm (1708); Death (1802); Emotional Changes (1831); Unspecified Infection (1930); Inflammation (1932); Myocardial Infarction (1969); Urinary Retention (2119); Burning Sensation (2146); Urinary Frequency (2275); Discomfort (2330)

Event Date 12/03/2012

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced emotional distress and a product problem.It was also reported that the plaintiff experienced recurrent abdominal and suprapubic discomfort, bladder infection, low back pain, urinary frequency, dribbling during urination, recurrent cystitis, incomplete bladder emptying, and urinary tract burning.Furthermore, it was reported that the plaintiff died.The causes of death reported were ruptured abdominal aortic aneurysm and acute myocardial infarction.Related to mfr # 2183959-2015-00610.

• Brand Name: AMS MINIARC SLING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• 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: 5339018
• MDR Text Key: 34815041
• Report Number: 2183959-2015-00609
• Device Sequence Number: 1
• Product Code: PAH
• 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: 03/12/2013

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: 08/26/2012
• Device Catalogue Number: 720046-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 12/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2009
• 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 ANTERIOR
• Patient Outcome(s): Death
• Patient Age: 59 YR