FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING WAND
MDR report key: 1172602
·
Received September 19, 2008
Report
- Report Number
- 1644487-2008-02262
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- August 22, 2008
- Report Date
- August 22, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
OTHER - DEVICE FAILURE WAS CONFIRMED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
THE REPORTER INDICATED THAT SHE WAS UNABLE TO USE HER VNS PROGRAMMING WAND TO INTERROGATE A PATIENT'S VNS DEVICE AND THAT THERE WAS A "BIG CUT" IN THE SERIAL ADAPTER CORD. THE PROGRAMMING WAND WAS RETURNED TO THE MANUFACTURER AND THE REPORTED EVENTS WERE CONFIRMED. PRODUCT ANALYSIS REVEALED THAT THE EVENT WAS RELATED TO AN OPEN CONDUCTOR AND PHYSICAL DAMAGE TO THE SERIAL DATE CABLE. A KNOWN GOOD BENCH SERIAL DATA CABLE AND BATTERY WAS INSTALLED, AND ALL COMMUNICATION ERRORS WERE RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING WAND | UNKNOWN | LYJ | CYBERONICS, INC. | 201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |