MalfunctionHAW
NDI PASSIVE SPHERES
Received Jun 8, 2015 · Event occurred May 1, 2015
Report 3002743211-2015-00029 · MDR key 4825253
Device
Product problems
- Device Operates Differently Than Expected
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 REPLACED SPHERES AND TRACKING RETURNED TO NORMAL. SITE 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.