MalfunctionHAW
NDI PASSIVE SPHERES
Received Jul 20, 2015 · Event occurred Jan 9, 2015
Report 3002743211-2015-00039 · MDR key 4925046
Device
Product problems
- Data Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE DISCARDED BY USER.
Description of Event or Problem
THIS EVENT WAS COMMUNICATED BY MEDTRONIC NAVIGATION WHO REPORTED THAT A SITE HAD SPHERES THAT DID NOT TRACK. SITE DID NOT RECORD LOT INFORMATION, DID NOT TAKE PICTURES AND DISPOSED OF THE PRODUCT. SITE REPLACED SPHERES AND THE NEW SPHERES WERE ABLE TO TRACK. COMPLAINANT DID NOT REPORT ANY PATIENT/USER INJURY, DEATH OR OTHER SERIOUS DETERIORATION IN HEALTH.