MalfunctionHAW
NDI PASSIVE SPHERES
Received Aug 10, 2015 · Event occurred Jul 2, 2015
Report 3002743211-2015-00042 · MDR key 4988377
Device
Product problems
- Positioning Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
DEVICE NOT RETURNED.
Description of Event or Problem
THIS EVENT WAS COMMUNICATED BY A MEDTRONIC REPRESENTATIVE WHO REPORTED THAT A SITE ((B)(6) HOSPITAL) HAD SPHERES THAT DID NOT TRACK. LOT NUMBER IS UNKNOWN. SITE DID NOT TAKE ANY PICTURES AND DISCARDED DEVICE. COMPLAINANT REPORTED THAT THERE WAS NO PATIENT/USER INJURY, DEATH OR OTHER SERIOUS DETERIORATION IN HEALTH.