FDA Adverse Event
Malfunction
Summary report: N
THE FREEHAND SYSTEM
MDR report key: 288983
·
Received August 4, 2000
Report
- Report Number
- 1530440-2000-00003
- Event Type
- Malfunction
- Date Received
- August 4, 2000
- Date of Event
- July 1, 2000
- Report Date
- July 7, 2000
- Manufacturer
- NEUROCONTROL CORPORATION
- Product Code
- GZC
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT WAS IMPLANTED WITH FREEHAND SYSTEM HAND GRASP NEUROPROSTHESIS IN 1997. IN 1999, THE PT EXPERIENCED INTERMITTENT MALFUNCTION OF THE DEVICE THAT PROGRESSED TO IMPLANT FAILURE TO DELIVER STIMULATION. THE PT HAD THE FREEHAND IMPLANTABLE RECEIVER STIMULATOR REPLACED IN 2000. DEVICE REPLACEMENT HAS RESTORED FUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THE FREEHAND SYSTEM | IMPLANTABLE HAND GRASP NEUROPROSTHESIS | GZC | NEUROCONTROL CORPORATION | 1060-1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |