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

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Incontinence (1928); Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Pain (1994); Sepsis (2067); Shock (2072); Multiple Organ Failure (3261)

Event Type  Death  

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced severe pelvic pain, swelling, urinary and bowel problems, painful intercourse, infections, recurrence, neuromuscular problems and worsening of incontinence.Furthermore, it was reported that the plaintiff died.The cause of death was reported as shock with multiple organ system failure and suspected sepsis.Related to manufacturer report #: 2183959-2014-63559.

Manufacturer Narrative

This was initially reported on the summary report dated 12/23/2014 under exemption #(b)(4).Lawyer filed report.

• Brand Name: AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka MN 55343
• Manufacturer Contact: sharon zurn, dir, quality ; 10700 bren road west; minnetonka, MN 55343 ; 9509306347
• MDR Report Key: 4615554
• MDR Text Key: 5653295
• Report Number: 2183959-2014-63558
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K082677
• 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: 09/05/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/05/2014
• Initial Date FDA Received: 03/17/2015
• 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: ELEVATE POSTERIOR
• Patient Outcome(s): Death