FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2081533
·
Received April 19, 2011
Report
- Report Number
- 1644487-2011-00841
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- March 23, 2011
- Report Date
- March 23, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A NEUROLOGIST THAT HER HANDHELD DEVICE FROZE AND DID NOT INTERROGATE HER PT'S GENERATORS. THE NEUROLOGIST TROUBLESHOT THE DEVICE BY PERFORMING A HARD RESET, UNPLUGGING THE HANDHELD FROM THE WALL, AND REPLACING THE PROGRAMMING WAND'S BATTERY; HOWEVER, THE ISSUE WAS NOT RESOLVED. WHEN SHE TRIED ANOTHER PROGRAMMING SYSTEM THE INTERROGATION WAS COMPLETED SUCCESSFULLY. A NEW SET OF PROGRAMMING SYSTEM WERE SENT TO THE PHYSICIAN BUT THE OLD HANDHELD, WAND, AND FLASHCARD WERE NOT RETURNED FOR PRODUCT ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 857134 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |