FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2050208
·
Received April 1, 2011
Report
- Report Number
- 1644487-2011-00692
- Event Type
- Malfunction
- Date Received
- April 1, 2011
- Date of Event
- January 1, 2010
- Report Date
- March 2, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
WHEN A GENERATOR WAS RECEIVED BY THE MFR AFTER EXPLANT, IT WAS FOUND PROGRAMMED TO SETTINGS THAT ARE CHARACTERISTIC OF A INTERRUPTION OF SYSTEM DIAGNOSTIC TEST. IT IS UNK IF THE INTERRUPTION OF SYSTEM DIAGNOSTIC TEST OCCURRED AT EXPLANT SURGERY OR PRIOR TO SURGERY AND IF IT WAS INTENTIONALLY LEFT AT THOSE SETTINGS. GOOD FAITH ATTEMPTS FOR MORE INFO HAVE BEEN UNSUCCESSFUL TO DATE.
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 | 10 YR |