MalfunctionHAW
NDI PASSIVE SPHERES
Received Aug 19, 2015 · Event occurred Jul 10, 2015
Report 3002743211-2015-00046 · MDR key 5015571
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 (B)(4) REPRESENTATIVE WHO REPORTED THAT A SITE ((B)(6) HOSPITAL) HAD SPHERES THAT DID NOT TRACK. SITE REPLACED SPHERES WITH NEW ONES AND CONTINUED WITH PROCEDURE WITH NO ADVERSE EVENT. 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.