FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2250808
·
Received September 16, 2011
Report
- Report Number
- 1644487-2011-02172
- Event Type
- Malfunction
- Date Received
- September 16, 2011
- Date of Event
- July 14, 2010
- Report Date
- September 14, 2011
- Manufacturer
- CYBERONICS
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS OF PROGRAMMING HISTORY.
Description of Event or Problem · 1
DURING MANUFACTURER REVIEW OF A PATIENT'S VNS PROGRAMMING HISTORY, IT WAS NOTED A SYSTEMS TEST DID NOT COMPLETE ON (B)(6) 2010 AS THERE IS AN INTERROGATION OF 0MA/20HZ/500 PULSEWIDTH/30 SEC ON/60 MIN OFF. THE SETTINGS WERE IMMEDIATELY CORRECTED, BUT THE OFF TIME WAS SET TO 120 MINUTES AND PREVIOUSLY BEFORE THE SYSTEMS TEST THE OFF TIME WAS 1.1 MINUTES. THE PHYSICIAN WAS NOTIFIED OF THE OFF TIME DISCREPANCY AND PROGRAMMING ANOMALY OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | PROGRAMMING SOFTWARE | LYJ | CYBERONICS | MODEL 250 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR |