FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2821479
·
Received November 6, 2012
Report
- Report Number
- 1644487-2012-02904
- Event Type
- Malfunction
- Date Received
- November 6, 2012
- Date of Event
- July 23, 2012
- Report Date
- October 9, 2012
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
NO FURTHER INFORMATION HAS BEEN ATTAINED AFTER GOOD FAITH ATTEMPTS HAVE BEEN MADE.
Description of Event or Problem · 1
AN EXPLANTED GENERATOR WAS RETURNED FOR ANALYSIS AND IT WAS NOTED THAT IT WAS RECEIVED AT SETTINGS INDICATIVE OF A FAULTED SYSTEM DIAGNOSTIC TEST (0 MA / 20 SF / 500 PW / 30 SEC ON TIMES / 60 MINUTES OFF TIME). GOOD FAITH ATTEMPTS ARE BEING PERFORMED FOR FURTHER DETAILS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR |