FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL UNK
MDR report key: 1143661
·
Received August 28, 2008
Report
- Report Number
- 1644487-2008-02016
- Event Type
- Injury
- Date Received
- August 28, 2008
- Date of Event
- January 1, 1996
- Report Date
- July 29, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
HAN P, FREI MG, OSORIO I. PROBABLE MECHANISMS OF ACTION OF VAGUS NERVE STIMULATION IN HUMANS WITH EPILEPSY: IS A WINDOW INTO THE BRAIN [ABSTRACT]? EPILEPSIA 1996;37 (5SUPPL):83S.
Description of Event or Problem · 1
IT WAS REPORTED IN AN ARTICLE REVIEWED BY MANUFACTURER THAT VNS PATIENTS ARE EXPERIENCING BRADYCARDIA AND TACHYCARDIA WITH STIMULATION. A DECREASE IN R-R VARIABILITY IS SOMETIMES SEEN IN PATIENTS AT RISK OF SUDDEN CARDIAC DEATH. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL UNK | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |