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

Catalog Number 720093-01

Device Problem Missing Value Reason (3192)

Patient Problems Death (1802); Emotional Changes (1831); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Itching Sensation (1943); Pain (1994); Pneumonia (2011); Sepsis (2067); Swelling (2091); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Urinary Frequency (2275); Discomfort (2330)

Event Date 01/13/2011

Event Type  Death  

Manufacturer Narrative

(b)(4).Lawyer-filed report.

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced incontinence, urgency, urine retention, vaginal burning, leakage, dribbling, urinary tract infection, bladder dysfunction, pseudomonas, swelling, scant discharge, pressure, itching in vaginal area, vaginal soreness, atrophic vaginitis, urinary hesitancy, frequency and discomfort.It was also reported that the plaintiff allegedly experienced pain, infection, emotional distress and a product problem.Furthermore, it was reported that the plaintiff died.The cause of death reported were sepsis and pneumonia.Related to manufacturer report #: 2183959-2014-37268.

• 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: 5050332
• MDR Text Key: 24872209
• Report Number: 2183959-2014-37272
• 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: consumer,other
• Reporter Occupation: Attorney
• Report Date: 08/30/2013

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: 12/07/2013
• Device Catalogue Number: 720093-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2010
• 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: 93 YR
• Patient Weight: 65