FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1132731
·
Received August 21, 2008
Report
- Report Number
- 1644487-2008-01973
- Event Type
- Malfunction
- Date Received
- August 21, 2008
- Date of Event
- January 1, 2008
- Report Date
- July 24, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
INITIAL REPORTER INDICATED TO A THERAPEUTIC CONSULTANT THAT THEY HAD BEEN HAVING ISSUES WITH THEIR HANDHELD FOR THE LAST FEW MONTHS. THE HANDHELD WILL "NOT HOLD A CHARGE" DESPITE HAVING GONE THROUGH ALL THE TROUBLESHOOTING STEPS. THE PRODUCT IS AT THE MANUFACTURER PENDING COMPLETION OF PRODUCT ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 521421 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |