MalfunctionHAW
NDI PASSIVE SPHERES
Received Jun 8, 2015 · Event occurred Apr 15, 2015
Report 3002743211-2015-00028 · MDR key 4825205
Device
Product problems
- Mechanics Altered
Patient
Not reported
- No Known Impact Or Consequence 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 WOULD NOT TRACK. SITE REPORTED SPHERES APPEARED SCUFFED BUT DID NOT TAKE ANY PICTURES OR RECORD LOT NUMBER. COMPLAINANT REPORTED THAT THERE WAS NO DELAY OR ADVERSE EVENT TO THE PATIENT. THERE WAS NO PATIENT/USER INJURY, DEATH OR OTHER SERIOUS DETERIORATION IN HEALTH.