FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 3201066
·
Received July 2, 2013
Report
- Report Number
- 1644487-2013-02005
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- September 20, 2010
- Report Date
- June 4, 2013
- Manufacturer
- CYBERONICS
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
DURING REVIEW OF PROGRAMMING HISTORY, IT WAS NOTED THAT THIS DEVICE WAS INTERROGATED AT SETTINGS INDICATIVE OF A FAULTED DIAGNOSTIC TEST. THE SETTINGS WERE NOT CORRECTED AT THE TIME OF THE EVENT. AT THE FOLLOWING APPOINTMENT, THE PATIENT¿S DEVICE WAS REPROGRAMMED; HOWEVER, ANOTHER FAULTED TEST OCCURRED THAT WAS NOT CORRECTED AT THAT TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303327 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS | MODEL 250 | 857133 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |