FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING COMPUTER
MDR report key: 3090560
·
Received May 2, 2013
Report
- Report Number
- 1644487-2013-01224
- Event Type
- Malfunction
- Date Received
- May 2, 2013
- Date of Event
- April 1, 2013
- Report Date
- April 4, 2013
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE COMPANY REPRESENTATIVE WAS UNABLE TO LOCATE THE HANDHELD WITH THE REPORTED PROBLEM. THE NURSE REPORTED THAT THERE WAS NO KNOWN ISSUE ASSOCIATED WITH THEIR EQUIPMENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PHYSICIAN'S PROGRAMMING SYSTEM WAS NOT WORKING AND COMMUNICATING PROPERLY. IT WAS LATER REPORTED THAT THE ISSUES WITH THE DEVICE WAS THAT IT WOULD NOT HOLD A CHARGE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192854 | PROGRAMMING COMPUTER | PROGRAMMING COMPUTER | LYJ | CYBERONICS, INC. | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |