FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING WAND
MDR report key: 1022738
·
Received March 27, 2008
Report
- Report Number
- 1644487-2008-00808
- Event Type
- Malfunction
- Date Received
- March 27, 2008
- Date of Event
- February 25, 2008
- Report Date
- February 29, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
INITIAL REPORTER INDICATED THAT AFTER THREE ATTEMPTS AND CHANGING THE BATTERY IN THE PROGRAMMING WAND HE WAS NOT ABLE TO ESTABLISH COMMUNICATION WITH A GENERATOR. ANOTHER PROGRAMMING WAND WAS USED TO INTERROGATE THE PT SUCCESSFULLY. A DEVICE MALFUNCTION IS SUSPECTED WITH THE PROGRAMMING WAND. GOOD FAITH ATTEMPTS ARE BEING MADE TO HAVE THE WAND RETURNED TO THE MANUFACTURE FOR ANALYSIS.
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 |