FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2081398
·
Received April 22, 2011
Report
- Report Number
- 1644487-2011-00875
- Event Type
- Malfunction
- Date Received
- April 22, 2011
- Date of Event
- March 19, 2007
- Report Date
- March 24, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
DURING A REVIEW OF A PATIENT'S PROGRAMMING HISTORY AVAILABLE IN THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE, IT WAS FOUND THAT THE PATIENT EXPERIENCED A FAULTED SYSTEMS DIAGNOSTIC TEST ON (B)(6) 2007 THAT RESULTED IN THE PATIENT LEAVING WITH UNINTENDED SETTINGS. AFTER THE FAULTED DIAGNOSTIC, THE DEVICE WAS INTERROGATED AND REPROGRAMMED, HOWEVER, THE OFF TIME, MAGNET MODE PULSE WIDTH, AND MAGNET MODE ON TIME WERE NOT CORRECTED. THE SETTINGS WERE CORRECTED DURING A VISIT ON (B)(6) 2007. THERE WERE NO REPORTS OF ANY PATIENT ADVERSE EVENTS AS A RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |