FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL UNK
MDR report key: 1471018
·
Received September 11, 2009
Report
- Report Number
- 1644487-2009-01957
- Event Type
- Injury
- Date Received
- September 11, 2009
- Date of Event
- February 1, 2002
- Report Date
- August 14, 2009
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ARTICLE REFERENCE: ZAAIMI, B., GREBE, R., BERQUIN, P., PATRICK B. "VAGUS NERVE STIMULATION THERAPY INDUCES CHANGES IN HEART RATE OF CHILDREN DURING SLEEP". EPILEPSIA 48: 923-930. 2007.
Description of Event or Problem · 1
IT WAS REPORTED IN A SCIENTIFIC ARTICLE THAT STUDY PATIENT # 2 SHOWED CHANGE IN HEART RATE WHILE RECEIVING VAGUS NERVE STIMULATION. IT WAS INDICATED THAT THE CHANGE IN HEART RATE WAS RELATED TO VNS THERAPY. THERE WAS AN INCREASE IN HEART RATE NOTICED FOR THIS PARTICULAR CHILD PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL UNK | LYJ | CYBERONICS, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Required Intervention |