FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1006210
·
Received February 29, 2008
Report
- Report Number
- 1644487-2007-02159
- Event Type
- Death
- Date Received
- February 29, 2008
- Date of Event
- September 26, 2007
- Report Date
- October 3, 2007
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CLIN AUTON RES (2007), EXACERBATION OF ELECTRICAL STORM SUBSEQUENT TO IMPLANTATION OF A RIGHT VAGAL STIMULATOR. DOI 10.1007/S10286-007-0440-1. SHALABY, A, ET AL.
Description of Event or Problem · 1
REPORTER INDICATED A PT'S DEATH WAS POSSIBLY DUE TO EXACERBATION OF A LETHAL VENTRICULAR ARRHYTHMIA BY VNS THERAPY AND SEVERE UNDERLYING CARDIAC DISEASE. THE PT WAS IMPLANTED ON THE RIGHT VAGUS NERVE. THE PT WAS BURIED WITH THE VNS AND NO AUTOPSY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | NONE | LYJ | CYBERONICS, INC. | 102 | 012565 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Death |