FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 983384
·
Received January 24, 2008
Report
- Report Number
- 1644487-2008-00119
- Event Type
- Injury
- Date Received
- January 24, 2008
- Date of Event
- December 1, 2007
- Report Date
- December 26, 2007
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT A PT WANTS TO HAVE THE VNS DEVICE REMOVED, BECAUSE SHE FELT THAT AFTER A RECENT CT SCAN THE DEVICE WAS STIMULATING CONSTANTLY. IT WAS LATER REPORTED BY THE PHYSICIAN THAT HE HAD TESTED THE GENERATOR, AND HE "COULD TELL THAT HER VNS GENERATOR IS DEFINITELY NOT FIRING CONSTANTLY". THE GENERATOR WAS THEN PROGRAMMED TO 0MA AT THE PT'S REQUEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 13315 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |