InjuryFHK
SPARC SLING SYSTEMS
Received Jun 22, 2004 · Event occurred Dec 1, 2003
Report 2183959-2004-00028 · MDR key 531203
Device
Generic name
Sparc/other Sling Types
Manufacturer
American Medical Systems, Inc.Model number
72403656Catalog number
NA
Lot number
NI
Product problems
- Explanted
- Use of Device Problem
Patient
NO INFO
- Pain
- Perforation
- Body temperature, elevated
- Surgical procedure
- Surgical procedure, additional
Narrative
Description of Event or Problem
AMS RECEIVED INFORMATION THAT A PT WHO HAD A SPARC SLING SYSTEM PROCEDURE HAD REPORTED SEVERE PAIN POST-OP. SEVERAL DAYS POST-OP THE DOCTOR DETERMINED THAT HE PERFORATED THE BOWEL WHEN PLACING THE SPARC DEVICE. THE PT HAD ELEVATED TEMPERATURE AND PAIN. THE SPARC SLING WAS REMOVED AND THE BOWEL REANASTOMIZED.