FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2170958
·
Received June 30, 2011
Report
- Report Number
- 1644487-2011-01434
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- May 23, 2011
- Report Date
- May 31, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
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
A PHYSICIAN'S HAND-HELD DEVICE WAS SAID TO NO LONGER BE HOLDING A CHARGE, WHICH HAD BEGUN APPROX ONE WEEK PREVIOUSLY. THE PHYSICIAN GENERALLY STORED THE DEVICE IN HIS FILING CABINET, AND THERE WAS NO SWELLING REPORTED ON THE BATTERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 885473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |