FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2951114
·
Received February 8, 2013
Report
- Report Number
- 1644487-2013-00350
- Event Type
- Malfunction
- Date Received
- February 8, 2013
- Date of Event
- December 19, 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
- CA, US
- Reporter Occupation
- PHYSICIAN
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 A FAULTED SYSTEM DIAGNOSTIC TEST OCCURRED ON (B)(6) 2005 WHICH CHANGED THE SETTINGS TO UNINTENDED PARAMETERS. A FINAL INTERROGATION WAS PERFORMED, BUT THE SETTINGS WERE NOT CORRECTED UNTIL THE SUBSEQUENT VISIT ON (B)(6) 2006. MANUFACTURER LABELING INDICATES TO PERFORM FINAL INTERROGATIONS TO IDENTIFY SUCH PROGRAMMING ANOMALIES AND CORRECT THE SETTINGS PRIOR TO THE PATIENT LEAVING THE CLINIC. NO PATIENT ADVERSE EVENTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 54077 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS INC | MODEL 250 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |