MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS MINIARC PRECISE SINGLE-INCISION SLING

Catalog Number 720791-01

Device Problem Extrusion (2934)

Patient Problems Erosion (1750); Death (1802); Fistula (1862); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Perforation (2001); Scar Tissue (2060); Urinary Tract Infection (2120); Urinary Frequency (2275); Blood Loss (2597); Dysuria (2684)

Event Type  Death  

Event Description

It was reported by the plaintiff's atty that the plaintiff allegedly experienced erosion, pain, infection, extrusion, bowel problems, organ perforation, fistulae, recurrence, bleeding, dyspareunia, neuromuscular problems and vaginal scarring.It was also reported that the plaintiff experienced suprapubic pain, kidney infections, burning urination, hematuria, nocturia, urinary frequency, urinary tract infections, weak stream, stress urinary incontinence, and urgency.It was furthermore reported that the plaintiff died.The causes of death were reported as adult respiratory distress syndrome due to pneumonia and cerebral vascular accident.Related to mfr reports 2183959-2014-10600, 2183959-2014-10705.

Manufacturer Narrative

This was initially reported on the summary report dated august 30 2014 under exemption (b)(4).Lawyer-filed report.

• Brand Name: AMS MINIARC PRECISE SINGLE-INCISION SLING
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka MN 55343
• Manufacturer Contact: sharon zurn, dir, qual compl ; 10700 bren road west; minnetonka, MN 55343 ; 9529306347
• MDR Report Key: 4377586
• MDR Text Key: 5287014
• Report Number: 2183959-2014-10668
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/03/2013

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: 02/16/2012
• Device Catalogue Number: 720791-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/03/2013
• Initial Date FDA Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2011
• 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: BOSTON SCIENTIFIC COAPTITE; MONARC; ELEVATE ANTERIOR
• Patient Outcome(s): Death