FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2224613
·
Received August 26, 2011
Report
- Report Number
- 1644487-2011-02004
- Event Type
- Malfunction
- Date Received
- August 26, 2011
- Date of Event
- March 5, 2008
- Report Date
- August 22, 2011
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
DURING MANUFACTURER REVIEW OF A PATIENT'S VNS PROGRAMMING HISTORY, IT WAS NOTED A PARTIAL PROGRAMMING EVENT OCCURRED ON (B)(6) 2008 WHICH SET THE OUTPUT CURRENT TO 0MA AND THE OFF TIME TO 60 MINUTES. THERE WAS NO FINAL INTERROGATION TO VERIFY THE SETTINGS WERE AS INTENDED. THE SETTINGS WERE CORRECTED ON OR BEFORE THE NEXT INTERROGATION DATE OF (B)(6) 2008, WHEN THE OUTPUT CURRENT WAS NOTED TO BE 2.25MA AND THE OFF TIME WAS 1.1 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS INC | MODEL 250 | 521379 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |