FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING WAND
MDR report key: 1132729
·
Received August 21, 2008
Report
- Report Number
- 1644487-2008-01979
- Event Type
- Malfunction
- Date Received
- August 21, 2008
- Date of Event
- July 30, 2008
- Report Date
- July 30, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
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
IT WAS REPORTED THAT A PROGRAMMING SYSTEM WAS PRODUCING COMMUNICATION ERRORS WHEN TRYING TO COMMUNICATE WITH A DEMO GENERATOR. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. THE PROGRAMMING WAND WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. PRODUCT ANALYSIS REVEALED THAT THE SERIAL ADAPTER CABLE HAD AN INTERMITTENT CONDUCTOR WHICH WAS PRODUCING THE COMMUNICATION ERRORS.
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 |