FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1191918
·
Received October 1, 2008
Report
- Report Number
- 1644487-2008-02373
- Event Type
- Malfunction
- Date Received
- October 1, 2008
- Date of Event
- September 2, 2008
- Report Date
- September 2, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PHYSICIAN'S HANDHELD DEVICE DOES HOLD CHARGE AS LONG AS IT USED TO. THE PHYSICIAN STATED THAT HE KEEPS IT CHARGED IN WHEN NOT IN USE, HOWEVER, THE BATTERY WILL RUN OUT FASTER THAN BEFORE. A REPLACEMENT HANDHELD WAS SENT TO THE PHYSICIAN TO USE. GOOD FAITH ATTEMPTS TO OBTAIN THE HANDHELD FROM THE PHYSICIAN FOR PRODUCT ANALYSIS HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | MUZ | CYBERONICS, INC. | 250 | 521419 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR |