MalfunctionHAW
NDI PASSIVE SPHERES
Received Jun 30, 2015 · Event occurred May 22, 2015
Report 3002743211-2015-00035 · MDR key 4878179
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THIS EVENT WAS COMMUNICATED BY MEDTRONIC NAVIGATION WHO REPORTED THAT A SITE ((B)(6) HOSPITAL) HAD SPHERES THAT DID NOT TRACK. SITE REPLACED SPHERES AND THE NEW SPHERES WERE ABLE TO TRACK. SITE DISPOSED OF PRODUCT, DID NOT TAKE ANY PICTURES OR RECORD LOT NUMBER.COMPLAINANT REPORTED THAT THERE WAS NO PATIENT/USER INJURY, DEATH OR OTHER SERIOUS DETERIORATION IN HEALTH.