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

Catalog Number 72403830

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Emotional Changes (1831); Pain (1994); Injury (2348)

Event Type  Death  

Event Description

It was reported by the plaintiff's atty that the plaintiff allegedly experienced emotional distress, unspecific injury and a product problem.Furthermore, it was reported that the plaintiff died.The cause of death was cardiorespiratory arrest and atherosclerotic heart disease.

Manufacturer Narrative

This was initially reported on the summary report dated (b)(6) 2014 under exemption (b)(4).Lawyer filed report.

Event Description

Additional information received indicated that the plaintiff allegedly experienced pain and recurrence.

• Brand Name: AMS MONARC SLING SYSTEM
• 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: 4377585
• MDR Text Key: 19765841
• Report Number: 2183959-2014-19608
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,consumer,other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/25/2014

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: 09/01/2010
• Device Catalogue Number: 72403830
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/25/2014
• Initial Date FDA Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2009
• 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
• Patient Outcome(s): Death