FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL 102
MDR report key: 4121597
·
Received September 26, 2014
Report
- Report Number
- 1644487-2014-02492
- Event Type
- Death
- Date Received
- September 26, 2014
- Date of Event
- June 16, 2010
- Report Date
- September 2, 2014
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE FUNERAL HOME REPORTED THAT THE PATENT DIED IN A NURSING FACILITY DUE TO NATURAL CAUSES RESULTING FROM METASTATIC LUNG CANCER. IT IS NOT BELIEVED THAT THE VNS PRODUCTS WERE REMOVED PRIOR TO BURIAL, AS FUNERAL HOME ONLY EXPLANTS PRODUCTS FOR CREMATIONS. AN INTERNAL MANUFACTURER REVIEW OF THE DEATH CLASSIFIED THE DEATH AS UNLIKELY SUDEP.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY ON (B)(6) 2010. THE CAUSE OF DEATH AND ITS RELATIONSHIP TO VNS ARE UNKNOWN. BASED ON THE LIMITED AVAILABLE INFORMATION ABOUT THE PATIENT¿S DEATH, AN INTERNAL CLASSIFICATION HAS DETERMINED THAT THE DEATH MAY BE POSSIBLE SUDEP. NO FURTHER INFORMATION RELEVANT TO THE PATIENT¿S DEATH HAS BEEN RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 602105 | PULSE GEN MODEL 102 | GENERATOR | LYJ | CYBERONICS, INC. | 102 | 8457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Death |