MalfunctionIYJ
PATIENT KIT ESSENTIALS
Received Apr 20, 2007 · Event occurred Mar 21, 2007
Report 1644487-2007-00311 · MDR key 917493
Device
Product problems
- Crack
- Device Issue
Patient
4 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
REPORTER INDICATED THAT THE MAGNET HAD CRACKED AND WAS NO LONGER WORKING. THE PT WAS NOT AVAILABLE TO PERFORM TROUBLESHOOTING TO DETERMINE IF THE CRACKED MAGNET WAS INITIATING A MAGNET MODE STIMULATION. THE CAUSE OF THE CRACKED MAGNET IS UNKNOWN.
Additional Manufacturer Narrative
DEVICE FAILURE SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.