FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1002790
·
Received February 26, 2008
Report
- Report Number
- 1644487-2008-00412
- Event Type
- Malfunction
- Date Received
- February 26, 2008
- Date of Event
- January 10, 2008
- Report Date
- January 28, 2008
- 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
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
THE REPORTER INDICATED THE SCREEN ON THE VNS THERAPY PROGRAMMING HANDHELD WAS FREEZING AFTER INTERROGATION AND DURING PROGRAMMING. THE REPORTER STATED, THE HANDHELD SCREEN WOULD TURN GRAY. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. THE HANDHELD AND PROGRAMMING SOFTWARE HAVE BEEN RETURNED TO THE MFR FOR PRODUCT ANALYSIS (PENDING RESULTS).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250-7.1 | 530641 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |