FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL UNKNOWN
MDR report key: 1982468
·
Received February 3, 2011
Report
- Report Number
- 1644487-2011-00170
- Event Type
- Death
- Date Received
- February 3, 2011
- Date of Event
- January 1, 1994
- Report Date
- January 10, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
KOURTROMANIDIS M. VNS PT WITH PREVIOUS UNSUCCESSFUL RESECTIVE EPILEPSY SURGERY: ANTIEPILEPTIC AND PSYCHOTROPIC EFFECTS. ACTA NEUROL SCAND 2003:107:117-121.
Description of Event or Problem · 1
AN ARTICLE WAS RECEIVED FOR REVIEW CALLED: VNS IN PTS WITH PREVIOUS UNSUCCESSFUL RESECTIVE EPILEPSY SURGERY: ANTIEPILEPTIC AND PSYCHOTROPIC EFFECTS. IN THE ARTICLE, IT MENTIONS ONE PT DIED ONE MONTH AFTER VNS IMPLANTATION FROM SUDEP. NO FURTHER INFO WAS REPORTED ON THE PT IN THE ARTICLE. EXACT DATE OF DEATH UNK. ARTICLE REPORTING ON PT IMPLANTED WITH THE VNS BETWEEN 1994-1999. THE RELATIONSHIP OF THEIR DEATH TO THE VNS IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL UNKNOWN | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |