MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS SPARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 72403656

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Erosion (1750); Death (1802); Micturition Urgency (1871); Inflammation (1932); Urinary Tract Infection (2120); Urinary Frequency (2275); Discomfort (2330); Dysuria (2684); No Code Available (3191); Constipation (3274)

Event Type  Death  

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced recurrent urinary tract infection, bladder lesion, erosion, dysuria, microhematuria, leaking, urgency and frequency.It was also reported that the plaintiff allegedly experienced perineal irritation, worsening stress incontinence, severe inflammation, pain, bleeding, discomfort and a product problem.Furthermore, it was reported that the plaintiff died.The cause of death was reported as cardiopulmonary respiratory arrest due to acute respiratory failure and sepsis.

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 indicates that the plaintiff experienced chronic constipation, vaginal abscess, and renal insufficiency.

• Brand Name: AMS SPARC SLING 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 ; 10700 bren road west; minnetonka, MN 55343 ; 9529306347
• MDR Report Key: 4383547
• MDR Text Key: 14879837
• Report Number: 2183959-2014-52127
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011251
• 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,Followup
• Report Date: 08/06/2013

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: 05/13/2011
• Device Catalogue Number: 72403656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/06/2013
• Initial Date FDA Received: 12/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2008
• 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