FDA Adverse Event
Death
Summary report: N
NCP PULSE GENERATOR
MDR report key: 492814
·
Received October 30, 2003
Report
- Report Number
- 1644487-2003-00621
- Event Type
- Death
- Date Received
- October 30, 2003
- Date of Event
- September 29, 2003
- Report Date
- September 30, 2003
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT VNS PATIENT PASSED AWAY DURING A SCOLIOSIS SURGERY ON THEIR BACK. IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS PROGRAMMED TO "OFF" PRIOR TO THE SURGERY AND THAT THE DEATH DOES NOT APPEAR TO BE RELATED TO THE NCP SYSTEM. THE CAUSE OF DEATH WAS REPORTED AS CARDIAC ARREST. 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 | 3302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | Death | EXPIR DATE 04/30/2003, DATE OF MFG 05/08/2001,| MODEL 300-20 NCP BIPOLAR LEAD,| STERILIZATION LOT NO. 3028. |