FDA Adverse Event
Death
Summary report: N
CYBERONICS NEUROCYBERNETIC PROSTHESIS
MDR report key: 318103
·
Received February 23, 2001
Report
- Report Number
- 1644487-2001-00141
- Event Type
- Death
- Date Received
- February 23, 2001
- Date of Event
- April 1, 1997
- Report Date
- September 9, 1997
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DESCRIBE EVENT OR PROBLEM: PT DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 7587 | CYBERONICS NEUROCYBERNETIC PROSTHESIS | NEUROSTIMULATOR | LYJ | CYBERONICS, INC. | 100 | ED-1934 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Death | MODEL 300-20 BIPOLAR LEAD. |