MalfunctionHAW
NDI PASSIVE SPHERES
Received Jun 19, 2015 · Event occurred May 19, 2015
Report 3002743211-2015-00033 · MDR key 4856889
Device
Product problems
- Positioning Problem
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) HAD SPHERES THAT WOULD NOT TRACK. SITE REPLACED SPHERES AND TRACKING RETURNED TO NORMAL. 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.