FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL UNK
MDR report key: 1114028
·
Received August 13, 2008
Report
- Report Number
- 1644487-2008-01872
- Event Type
- Injury
- Date Received
- August 13, 2008
- Date of Event
- December 20, 2001
- Report Date
- July 16, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ARTICLE REFERENCE: MARK, FREI G., AND IVAN OSORIO. "LEFT VAGUS NERVE STIMULATION WITH THE NEUROCYBERNETIC PROSTHESIS HAS COMPLEX EFFECTS ON HEART RATE AND ON ITS VARIABILITY IN HUMANS." EPILEPSIA 42 (2001): 1007-0016.
Description of Event or Problem · 1
IT WAS REPORTED IN A SCIENTIFIC ARTICLE THAT A VNS PT EXPERIENCED TACHYCARDIA DURING THE FIRST HALF OF STIMULATION, FOLLOWED BY BRADYCARDIA DURING THE SECOND; A POST-STIMULUS "REBOUND" TACHYCARDIA EVENT WAS ALSO SEEN. THE REPORTER INDICATED THAT PT/PRODUCT INFO FOR THIS STUDY IS UNAVAILABLE AS THE DATA HAS BEEN DE-IDENTIFIED.
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 |