FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3231782
·
Received July 17, 2013
Report
- Report Number
- 1644487-2013-02161
- Event Type
- Malfunction
- Date Received
- July 17, 2013
- Date of Event
- September 23, 2008
- Report Date
- June 25, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
ON (B)(6) 2013 DURING REVIEW OF THE PATIENT¿S PROGRAMMING HISTORY IT WAS OBSERVED THAT ON (B)(6) 2008 A FAULTED SYSTEM DIAGNOSTICS CHANGED THE PATIENT¿S SETTINGS TO OUTPUT=1MA/FREQUENCY=20HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=60MIN/ MAGNET OUTPUT=1MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=30SEC. NO FINAL INTERROGATION WAS PERFORMED AND IT WASN¿T UNTIL THE PATIENT¿S VISIT ON SEPTEMBER 29, 2008 THAT THE PATIENT WAS REPROGRAMMED TO INTENDED SETTINGS. NO PATIENT ADVERSE EVENTS WERE REPORTED TO HAVE OCCURRED DUE TO THIS SETTINGS CHANGE. THE HIGH IMPEDANCE EVENT HAS PREVIOUSLY BEEN REPORTED ON MFR. REPORT # 1644487-2008-01209.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 332621 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS INC | MODEL 250 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR |