MalfunctionHAW
NDI PASSIVE SPHERES
Received Jul 23, 2015 · Event occurred Jun 19, 2015
Report 3002743211-2015-00041 · MDR key 4934949
Device
Product problems
- Positioning Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE NOT RETURNED.
Description of Event or Problem
THIS EVENT WAS COMMUNICATED BY MEDTRONIC REPRESENTATIVE 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. LOT NUMBER IS UNKNOWN. ATTEMPTED TO CONTACT INITIAL COMPLAINANT BUT NO REPORTS OF ANY PATIENT/USER INJURY, DEATH OR OTHER SERIOUS DETERIORATION IN HEALTH.