FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL UNKNOWN
MDR report key: 2180777
·
Received July 22, 2011
Report
- Report Number
- 1644487-2011-01669
- Event Type
- Death
- Date Received
- July 22, 2011
- Date of Event
- May 23, 2011
- Report Date
- June 23, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD PASSED AWAY. THE PHYSICIAN HAS NOT SEEN THIS PT IN A LONG TIME AND THE PT WAS BEING FOLLOWED BY AN UNK PHYSICIAN, SO THE DETAILS SURROUNDING DEATH ARE UNK AT THIS TIME.
Description of Event or Problem · 1
EVALUATION BY A MANUFACTURER NURSE REVEALS THAT THE PATIENT'S DEATH IS A POSSIBLE SUDEP. ATTEMPTS FOR FURTHER INFORMATION 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 | 30 YR | Death |