MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE; SURGICAL MESH

Device Problem Extrusion (2934)

Patient Problems Cardiac Arrest (1762); Death (1802); Micturition Urgency (1871); Inflammation (1932); Irritation (1941); Pain (1994); Urinary Tract Infection (2120); Depression (2361); Prolapse (2475); Hematuria (2558); Constipation (3274)

Event Date 07/01/2010

Event Type  Death  

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced hematuria, urinary tract infection, vaginal irritation, recurrent cystocele, pain, urinary urgency, mesh exposure, vaginitis, vaginal atrophy, pyuria, vulvar pain, pelvic pain, constipation, cystitis and depression.The plaintiff underwent mesh revision.The device was partially explanted.Furthermore, it was reported that the plaintiff died.The cause of death was reported as cardiac arrest.(b)(4).

• Brand Name: AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: erika merrick ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 5404300
• MDR Text Key: 37300087
• Report Number: 2183959-2016-00043
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• 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
• Date Manufacturer Received: 01/26/2016
• 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
• Treatment: TVT
• Patient Outcome(s): Life Threatening
• Patient Age: 84 YR
• Patient Weight: 55