FDA Adverse Event
Death
Summary report: N
NCP PULSE GENERATOR
MDR report key: 521010
·
Received April 16, 2004
Report
- Report Number
- 1644487-2004-00323
- Event Type
- Death
- Date Received
- April 16, 2004
- Date of Event
- January 8, 2004
- Report Date
- March 19, 2004
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT VNS PT HAD PASSED AWAY. CAUSE OF DEATH IS NOT KNOWN AT THIS TIME. IT WAS REPORTED THAT THE NCP SYSTEM WAS NOT RELATED TO THE CAUSE OF DEATH. THE PT EXPERIENCED A 51-75% REDUCTION IN SEIZURES WITH VNS THERAPY. THERE IS NO EVIDENCE AT THIS TIME THAT THE NCP SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NCP PULSE GENERATOR | PULSE GENERATOR | LYJ | CYBERONICS, INC. | 101 | 962 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Death | EXPIR DATE 9/30/2002, DATE OF MFG 9/15/2000,| STERILIZATION LOT NO. 736.| MEDICATIONS AT TIME OF DEATH INCLUDE: KEPPRA,| NEURONTIN| MODEL 300-20 NCP BIPOLAR LEAD, |