FDA Adverse Event
Death
Summary report: N
NCP PULSE GENERATOR
MDR report key: 642170
·
Received October 21, 2005
Report
- Report Number
- 1644487-2005-00701
- Event Type
- Death
- Date Received
- October 21, 2005
- Date of Event
- June 13, 2004
- Report Date
- September 23, 2005
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT VNS PATIENT HAD PASSED AWAY IN HOSPITAL EMERGENCY ROOM. CERTIFICATE OF DEATH LISTS SEIZURE DISORDER AS THE IMMEDIATE CAUSE OF DEATH. NO AUTOPSY WAS PERFORMED. THERE IS NO EVIDENCE AT THIS TIME THAT THE NCP SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. REPORT IS INCOMPLETE BECAUSE TREATING NEUROLOGIST DID NOT RESPOND COMPLETELY TO MANUFACTURER'S REQUEST FOR ADDITIONAL INFORMATION. THE NCP SYSTEM WAS NOT EXPLANTED PRIOR TO BURIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NCP PULSE GENERATOR | PULSE GENERATOR | LYJ | CYBERONICS, INC. | 101 | 1791 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Death |