FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING WAND
MDR report key: 1022731
·
Received March 27, 2008
Report
- Report Number
- 1644487-2008-00770
- Event Type
- Malfunction
- Date Received
- March 27, 2008
- Date of Event
- February 28, 2008
- Report Date
- February 28, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED THAT A SITE'S PROGRAMMING WAND COULD NOT BE USED TO COMMUNICATE WITH VNS GENERATORS. THE BATTERIES WERE REPORTED TO BE FINE. IT WAS REPORTED THAT WHEN ANOTHER WAND WAS SUBSTITUTED, COMMUNICATION WAS ESTABLISHED SUCCESSFULLY. PRODUCT ANALYSIS HAS BEEN COMPLETED ON THE PROGRAMMING WAND AND IT WAS FOUND THAT THE 9V BATTERY WAS DEPLETED AND THE SERIAL CABLE HAD AN INTERMITTENT CONDUCTOR. WHEN A KNOWN GOOD BATTERY AND SERIAL CABLE WERE SUBSTITUTED, COMMUNICATION COULD BE ESTABLISHED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING WAND | LYJ | CYBERONICS, INC. | 201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |