FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1203376
·
Received October 15, 2008
Report
- Report Number
- 1644487-2008-02507
- Event Type
- Malfunction
- Date Received
- October 15, 2008
- Date of Event
- September 19, 2008
- Report Date
- September 19, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INITIAL REPORTER INDICATED TO THE MANUFACTURING CONSULTANT THAT IHS HANDHELD COMPUTER "KEPT FREEZING." REPORTED IT WOULD FREEZE AFTER THE PATIENT WAS INTERROGATED AND THE CHECK MARK SHOWED UP. REINSERTION OF THE FLASHCARD RESOLVED THE PROBLEM; HOWEVER, IT HAS BEEN OCCURRING MORE FREQUENTLY AND THE PHYSICIAN WANTED A REPLACEMENT. THE HANDHELD AND 7.1 PROGRAMMING SOFTWARE ARE 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 | 521377 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |