MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS MONARC SLING SYSTEM

Device Problem Extrusion (2934)

Patient Problems Erosion (1750); Death (1802); Incontinence (1928); Unspecified Infection (1930); Pain (1994)

Event Type  Death  

Event Description

It was reported that the plaintiff experienced erosion, infection, pain, and incontinence.Furthermore, it was reported that the plaintiff died.The cause of death was reported as brain death and aneurysmal subarachnoid hemorrhage.

Manufacturer Narrative

This was initially reported on the summary report dated (b)(6) under exemption (b)(4).Lawyer filed report.

• Brand Name: AMS MONARC SLING SYSTEM
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka MN 55343
• Manufacturer Contact: sharon zurn, qual compl ; 10700 bren road west; minnetonka, MN 55343 ; 9529306347
• MDR Report Key: 4377582
• MDR Text Key: 5258367
• Report Number: 2183959-2014-17243
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/09/2013

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/09/2013
• Initial Date FDA Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Death