MalfunctionHAW
NDI PASSIVE SPHERES
Received Sep 18, 2015 · Event occurred Aug 12, 2015
Report 3002743211-2015-00053 · MDR key 5087809
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE DISCARDED BY SITE.
Description of Event or Problem
THIS EVENT WAS COMMUNICATED BY A MEDTRONIC (B)(4) REPRESENTATIVE FROM (B)(6) HOSPITAL. COMPLAINT WAS THAT THE SPHERES WERE NOT TRACKING. THEY REPLACED THE SPHERES AND WERE ABLE TO CONTINUE THE PROCEDURE. COMPLAINANT REPORTED THAT THERE WAS NO PATIENT/USER INJURY, DEATH OR OTHER SERIOUS DETERIORATION IN HEALTH. THE SPHERES WERE DISCARDED BY THE CUSTOMER. NO LOT NUMBER WAS RECORDED BY CUSTOMER. NO PICTURES WERE TAKEN BY THE CUSTOMER.