FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2230669
·
Received September 1, 2011
Report
- Report Number
- 1644487-2011-02038
- Event Type
- Malfunction
- Date Received
- September 1, 2011
- Date of Event
- June 18, 2009
- Report Date
- August 25, 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
Description of Event or Problem · 1
MANUFACTURER REVIEW OF A VNS PATIENT'S PROGRAMMING HISTORY REVEALED A FAULTED SYSTEMS DIAGNOSTICS TEST OCCURRED ON (B)(6) 2009 WHICH CHANGED THE VNS SETTINGS TO 1MA/20HZ/500 PULSEWIDTH/30 SECONDS ON/60 MINUTES OFF. THE SETTINGS WERE NOT CORRECTED UNTIL (B)(6) 2009.
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 | 57 YR |