FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3030873
·
Received April 2, 2013
Report
- Report Number
- 1644487-2013-00891
- Event Type
- Malfunction
- Date Received
- April 2, 2013
- Date of Event
- November 7, 2006
- Report Date
- March 13, 2013
- Manufacturer
- CYBERONICS
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
WHILE PERFORMING A BATTERY LIFE CALCULATION IT WAS NOTED THAT ON (B)(6) 2006 THE DEVICE WAS INTERROGATED, THEN PROGRAMMED TO 2MA / 30 SF / 500 PW / 30 SECONDS ON TIME / 5 MINUTES OFF TIME. A SYSTEM DIAGNOSTIC RESULTED IN "FAULT" AND CAUSED THE SETTINGS TO CHANGE TO 1/20/500/30/60 MINUTES OFF TIME, PRIOR TO THE PATIENT LEAVING THE VISIT THE DEVICE WAS REPROGRAMMED, HOWEVER NOT EVERY PARAMETER WAS CORRECTED AND THE PATIENT LEFT THE VISIT AT 2.0/30/500/30/60 MINUTES OFF TIME. THEIR OFF TIME WAS CORRECTED ON (B)(6) 2009.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 135338 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS | 250 | 521422 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |