MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 720093-01

Device Problem Extrusion (2934)

Patient Problems Erosion (1750); Death (1802); Emotional Changes (1831); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Pneumonia (2011); Chronic Obstructive Pulmonary Disease (COPD) (2237); Respiratory Failure (2484); Blood Loss (2597)

Event Date 07/12/2012

Event Type  Death  

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced erosion, vaginal bleeding, and urinary incontinence.It was also alleged that the plaintiff experienced pain, extrusion, infection, bowel problems, recurrence, dyspareunia, and emotional distress.Furthermore, it was also reported that the plaintiff died.No cause of death was reported.Related to manufacturer report #: 2183959-2014-24311.

Manufacturer Narrative

This was initially reported on the summary report dated june 30, 2014 under exemption (b)(4).Additionally, this was reported on the summary report dated (b)(4) 2014 under exemption (b)(4).Additionally, this was reported on the summary report dated june 18, 2015 under exemption (b)(4).Lawyer-filed report.

Event Description

Additional information received indicated that the cause of death reported was respiratory failure due to hospice acquired pneumonia, chronic obstructive pulmonary disease and smoking.

• Brand Name: AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM
• 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: 4951425
• MDR Text Key: 21183291
• Report Number: 2183959-2014-24309
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082677
• 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: 04/08/2014

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: 08/25/2012
• Device Catalogue Number: 720093-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2014
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2009
• 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
• Patient Age: 76 YR