FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2951138
·
Received February 8, 2013
Report
- Report Number
- 1644487-2013-00351
- 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) 2008, AND A FINAL INTERROGATION WAS NOT PERFORMED. UPON INITIAL INTERROGATION ON THE SUBSEQUENT VISIT ON (B)(6) 2008, THE SETTINGS WERE AT UNINTENDED PARAMETERS AT 0MA. THE SETTINGS WERE CORRECTED ON THIS SAME VISIT. MANUFACTURER LABELING INDICATES TO PERFORM A FINAL INTERROGATION PRIOR TO LEAVING THE CLINIC TO IDENTIFY SUCH PROGRAMMING ANOMALIES. NO PATIENT ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE ANOMALY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 53849 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS INC | MODEL 250 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |