FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1181364
·
Received September 23, 2008
Report
- Report Number
- 1644487-2008-02081
- Event Type
- Malfunction
- Date Received
- September 23, 2008
- Date of Event
- August 25, 2008
- Report Date
- August 25, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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. (SEE SCANNED PAGE).
Description of Event or Problem · 1
REPORTER INDICATED HIS DELL X5 HANDHELD COMPUTER DID NOT HOLD ITS CHARGE AS LONG AS IT SHOULD HAVE. HE STATED THAT HE ALWAYS KEEPS IT PLUGGED IN WHEN NOT IN USE, AND WHEN HE UNPLUGS IT, IT USUALLY LASTS FOR MANY HOURS. THIS TIME, HOWEVER, IT HELD ITS CHARGE FOR LESS THAN 2 HOURS WHICH IS UNUSUAL. PRODUCT HAS BEEN RETURNED TO MANUFACTURER, BUT PRODUCT ANALYSIS IS PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 | 521383 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |