FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL 101
MDR report key: 1692687
·
Received May 14, 2010
Report
- Report Number
- 1644487-2010-01157
- Event Type
- Death
- Date Received
- May 14, 2010
- Date of Event
- October 13, 2009
- Report Date
- April 14, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO THE MFR THAT THE VNS PT PASSED AWAY. THE CAUSE OF DEATH AND THE RELATIONSHIP BETWEEN THE EVENT AND VNS THERAPY ARE UNK AT THIS TIME. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO REGARDING THE PT'S DEATH HAVE BEEN UNSUCCESSFUL TO DATE.
Description of Event or Problem · 1
CAUSE OF DEATH INFORMATION OBTAINED FROM THE NATIONAL DEATH INDEX (NDI) WAS REVIEWED BY THE MANUFACTURER WHICH INDICATED THAT THE PATIENT'S CAUSE OF DEATH WAS UNDERLYING CAUSE EMPHYSEMA, UNSPECIFIED,CARDIAC ARREST, UNSPECIFIED. THERE IS NO ALLEGATION OR OTHER INFORMATION INDICATING THAT THE DEATH IS RELATED TO VNS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | CYBERONICS, INC. | 101 | 1090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Death |