FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3042540
·
Received April 9, 2013
Report
- Report Number
- 1644487-2013-00956
- Event Type
- Malfunction
- Date Received
- April 9, 2013
- Date of Event
- August 4, 2011
- Report Date
- March 11, 2013
- Manufacturer
- CYBERONICS
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY PERFORMED.
Description of Event or Problem · 1
DURING REVIEW OF THE PATIENT'S PROGRAMMING HISTORY AVAILABLE IN THE MANUFACTURER'S DATABASE, IT WAS OBSERVED THAT A FAULTED SYSTEM DIAGNOSTIC TEST OCCURRED ON (B)(6) 2011 WHICH CHANGED THE SETTINGS TO UNINTENDED PARAMETERS. THE DEVICE WAS TEMPORARILY PROGRAMMED OFF, AND THEN THE SETTINGS WERE PROGRAMMED BACK TO THEIR PREVIOUS SETTINGS. HOWEVER, THE PULSE WIDTH WAS NOT CORRECTED UNTIL SEVERAL VISITS LATER ON (B)(6) 2012. NO PATIENT ADVERSE EVENTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145723 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS | MODEL 250 | 882767 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |