FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING WAND
MDR report key: 1658409
·
Received April 9, 2010
Report
- Report Number
- 1644487-2010-00878
- Event Type
- Malfunction
- Date Received
- April 9, 2010
- Date of Event
- March 1, 2010
- Report Date
- March 12, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A VNS PHYSICIAN THAT THEIR WAND WAS WORKING INTERMITTENTLY DURING VNS INTERROGATIONS. TROUBLESHOOTING WAS PERFORMED, WHICH ISOLATED THE PROGRAMMING WAND AS THE SUSPECTED CAUSE OF THE COMMUNICATION DIFFICULTIES. GOOD FAITH ATTEMPTS TO OBTAIN THE PROGRAMMING WAND HAS BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING WAND | PROGRAMMING WAND | LYJ | CYBERONICS, INC. | 201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |