FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 1941272
·
Received December 16, 2010
Report
- Report Number
- 1644487-2010-02827
- Event Type
- Malfunction
- Date Received
- December 16, 2010
- Date of Event
- October 27, 2010
- Report Date
- November 16, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS IN THE OFFICE AND A SYSTEM DIAGNOSTIC TEST WAS PERFORMED. AS THE PT WAS AT 0.25 MA, WHEN THE SYSTEM DIAGNOSTICS WERE RUN, THE PT COULD NOT TOLERATE THE 1 MA STIMULATION DELIVERED, SO THE WAND WAS PULLED AWAY AND THE SYSTEM DIAGNOSTICS WERE INTERRUPTED. NO FINAL INTERROGATION WAS PERFORMED TO VERIFY CORRECT SETTINGS. THE PT LEFT THE OFFICE AND CAME BACK LATER IN THE DAY COMPLAINING OF STRONGER STIMULATION AND IT WAS FOUND THAT THE PT'S SETTINGS HAD BEEN RESET TO 1 MA DUE TO THE INTERRUPTED SYSTEM DIAGNOSTIC TEST. THE GENERATOR WAS TURNED OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | 521373 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |