FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL UNKNOWN
MDR report key: 1706380
·
Received May 28, 2010
Report
- Report Number
- 1644487-2010-01283
- Event Type
- Death
- Date Received
- May 28, 2010
- Date of Event
- April 1, 2010
- Report Date
- April 28, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT HAD DIED AT HOME IN (B) (6) 2010, DUE TO AN UNK REASON. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.
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 |