FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2092852
·
Received May 5, 2011
Report
- Report Number
- 1644487-2011-01002
- Event Type
- Malfunction
- Date Received
- May 5, 2011
- Report Date
- April 7, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 1
UPON MFR REVIEW OF PRODUCT ANALYSIS COMPLETED FOR A VNS GENERATOR EXPLANTED DUE TO PROPHYLACTIC REASONS IT WAS NOTED THE AS-RECEIVED SETTINGS WERE INDICATIVE OF A FAULTED SYSTEMS DIAGNOSTICS TEST (1MA/20HZ/500PW/30 SECONDS ON/60 MINS OFF). ATTEMPTS FOR FURTHER INFO FROM THE TREATING NEUROLOGIST AND SURGEON REGARDING WHEN THE FAULTED DIAGNOSTICS MAY HAVE OCCURRED ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | MODEL 250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Male |