FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN
MDR report key: 1190788
·
Received September 24, 2008
Report
- Report Number
- 1644487-2008-02243
- Event Type
- Malfunction
- Date Received
- September 24, 2008
- Date of Event
- August 18, 2008
- Report Date
- August 18, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO THE MANUFACTURER THAT THE ERROR MESSAGE "THERE IS AN ERROR ESTABLISHING COMMUNICATION WITH THE DEVICE" WAS RECEIVED ON THE HANDHELD WHILE INTERROGATING THE PATIENT'S DEVICE. ANOTHER HANDHELD AND WAND WERE USED TO INTERROGATE THE PATIENT'S DEVICE BUT RECEIVED THE SAME ERROR MESSAGE. TROUBLESHOOTING WAS PERFORMED AND THE USER WAS ADVISED TO UNPLUG THE HANDHELD FROM THE WALL WHEN INTERROGATING. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO REGARDING THE EVENT WERE UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN | MUZ | CYBERONICS, INC. | 102 | 013894 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |