MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS SPARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 72403656

Device Problem Insufficient Information (3190)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Emotional Changes (1831); High Blood Pressure/ Hypertension (1908); Pain (1994); Disability (2371); Blood Loss (2597)

Event Type  Death  

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced severe and permanent pain, suffering, disability, impairment, emotional distress and a product problem.It was reported by the plaintiff's attorney that the plaintiff allegedly experienced recurrence of urinary problems.It was additionally reported that the plaintiff died on (b)(6) 2014.The cause of death was reported as cardiopulmonary arrest, gi bleed, hypertension and reflux.

• Brand Name: AMS SPARC SLING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• 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: 5247007
• MDR Text Key: 32048290
• Report Number: 2183959-2015-00536
• Device Sequence Number: 1
• Product Code: OTN
• 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: 06/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/30/2013
• Device Catalogue Number: 72403656
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2010
• 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