FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2232842
·
Received September 2, 2011
Report
- Report Number
- 1644487-2011-02061
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- March 10, 2008
- Report Date
- August 10, 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
THE INCORRECT EVENT DATE WAS INADVERTENTLY REPORTED ON THE INITIAL MDR REPORT. THE CORRECT EVENT DATE IS PROVIDED.
Description of Event or Problem · 1
DURING MANUFACTURER REVIEW OF A PATIENT'S VNS PROGRAMMING HISTORY, IT WAS NOTED THAT ON (B)(6) 2008, THE PATIENT WAS INTERROGATED AND FOUND TO BE AT 0MA/20HZ/500 PULSEWIDTH/30 SEC ON/60 MIN OFF. THESE SETTINGS ARE INDICATIVE OF A FAULTED SYSTEMS DIAGNOSTICS TEST. AT THE PREVIOUS OFFICE VISIT ON (B)(6) 2008, A SYSTEMS DIAGNOSTICS TEST WAS PERFORMED BUT THERE WAS NO FINAL INTERROGATION TO VERIFY SETTINGS. IT IS LIKELY THE SYSTEMS TEST FAULTED AND CAUSED THE SETTINGS TO CHANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS INC | MODEL 250 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR |