MalfunctionGZC
FREEHAND
Received Sep 29, 2006
Report 1530440-2006-00001 · MDR key 858805
Device
Generic name
Implantable Neuroprosthesis For Hand Grasp
Manufacturer
Neurocontrol Corp.Model number
1060-1Catalog number
NA
Lot number
NA
Product problems
- Device remains implanted
- Malfunction
Patient
YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE IMPLANTABLE STIMULATOR MALFUNCTIONS. FIVE CHANNELS STOPPED AND 3 CHANNELS GENERATED ERRATIC STIMULATION. NO INJURY TO THE PT HAS BEEN REPORTED. THE STIMULATOR IS NOT A LIFE SUPPORTING DEVICE. THE DEVICE CONTROLS HAND GRASP FUNCTION OF SPINAL-CORD INJURED PTS.
Remedial action
- Other