FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1831811
·
Received September 8, 2010
Report
- Report Number
- 1644487-2010-02040
- Event Type
- Malfunction
- Date Received
- September 8, 2010
- Date of Event
- August 10, 2010
- Report Date
- August 10, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED THAT HER VNS (B)(4) HANDHELD KEPT GIVING A COMMUNICATION FAILED ERROR MESSAGE WHEN INTERROGATING THE VNS. AFTER TROUBLESHOOTING, IT WAS DECIDED THAT THE ISSUE WAS WITH THE VNS HANDHELD ITSELF. THE HANDHELD HAS BEEN REQUESTED FOR RETURN BUT HAS NOT BEEN RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 521405 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |