FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL 102
MDR report key: 4102844
·
Received September 19, 2014
Report
- Report Number
- 1644487-2014-02402
- Event Type
- Death
- Date Received
- September 19, 2014
- Date of Event
- March 13, 2010
- Report Date
- August 22, 2014
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
.
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. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION 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 MALIGNANT NEOPLASM OF BREAST, UNSPECIFIED (RECORD AXIS 1), UNSPECIFIED MENTAL RETARDATION (AXIS 2), INFANTILE CEREBRAL PALSY (AXIS 3), UNSPECIFIED, CARDIAC ARREST (AXIS 4). 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 |
|---|---|---|---|---|---|---|---|
| 584774 | PULSE GEN MODEL 102 | GENERATOR | LYJ | CYBERONICS, INC. | 102 | 014865 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Death |