FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2951003
·
Received February 8, 2013
Report
- Report Number
- 1644487-2013-00349
- Event Type
- Malfunction
- Date Received
- February 8, 2013
- Date of Event
- April 5, 2005
- Report Date
- January 16, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
REVIEW OF THE VNS PROGRAMMING HISTORY DATABASE IN-HOUSE REVEALED THAT UPON INITIAL INTERROGATION ON THE FIRST DATE IN THE HISTORY ((B)(6) 2005), THE DEVICE APPEARS TO BE UNINTENDED PARAMETERS THAT ARE INDICATIVE OF A FAULTED SYSTEM DIAGNOSTIC TEST OCCURRING. THE FIRST SYSTEM DIAGNOSTIC TEST ON THIS DATE WAS NOT PERFORMED UNTIL 12:55PM. THEREFORE, IT APPEARS THAT A PROGRAMMING ANOMALY OCCURRED SOMETIME PRIOR ON AN UNKNOWN DATE. THE PROGRAMMER DEVICE INFORMATION AND TIME OF OCCURRENCE IS UNKNOWN. THE PATIENT'S GENERATOR WAS IMPLANTED ON (B)(6) 2004, SO THE DEVICE WAS LIKELY NOT INTENDED TO BE AT THESE PARAMETERS. THE SETTINGS WERE CORRECTED ON (B)(6) 2005 PRIOR TO THE PATIENT LEAVING THE CLINIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 54835 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS INC | MODEL 250 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR |