FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3179730
·
Received June 20, 2013
Report
- Report Number
- 1644487-2013-01860
- Event Type
- Malfunction
- Date Received
- June 20, 2013
- Date of Event
- May 6, 2008
- Report Date
- May 30, 2013
- Manufacturer
- CYBERONICS
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
ON (B)(6) 2013 THE PATIENT¿S PROGRAMMING HISTORY WAS REVIEWED AND IT WAS OBSERVED THAT ON DATE OF IMPLANT, (B)(6) 2008, A FAULTED SYSTEM DIAGNOSTICS TEST OCCURRED THAT CHANGED THE PATIENTS¿ SETTINGS FROM OUTPUT=0MA/FREQUENCY=20HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=60MIN/MAGNET OUTPUT=0MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=30SEC 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. A FINAL INTERROGATION WAS NOT PERFORMED AND IT WASN¿T UNTIL THE PATIENT¿S NEXT VISIT ON (B)(6) 2008 THAT THE SETTINGS WERE CORRECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279663 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS | MODEL 250 | 523498 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR |