FDA Adverse Event
Malfunction
Summary report: N
PROGRAMMING SOFTWARE
MDR report key: 2100263
·
Received May 16, 2011
Report
- Report Number
- 1644487-2011-01094
- Event Type
- Malfunction
- Date Received
- May 16, 2011
- Date of Event
- January 1, 2010
- Report Date
- April 18, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
DURING MANUFACTURER PRODUCT ANALYSIS OF AN EXPLANTED VNS GENERATOR, IT WAS NOTED THE GENERATOR WAS SET TO DEFAULT SYSTEMS DIAGNOSTICS SETTINGS OF 1MA/20HZ/500 PULSEWIDTH/30 SEC ON/60 MIN OFF. THIS IS LIKELY DUE TO FAULTED SYSTEMS DIAGNOSTIC TEST EITHER AT THE TIME OF GENERATOR EXPLANT ON (B)(6) 2010, OR PRIOR TO THIS DATE. ATTEMPTS FOR FURTHER INFORMATION AND VNS PROGRAMMING HISTORY ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROGRAMMING SOFTWARE | LYJ | CYBERONICS, INC. | 250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR |