FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2020253
·
Received March 11, 2011
Report
- Report Number
- 1644487-2011-00537
- Event Type
- Death
- Date Received
- March 11, 2011
- Date of Event
- January 31, 2011
- Report Date
- February 11, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 1
RPTR INDICATED THAT A VNS PT HAD DIED DUE TO AN UNK REASON. THE PT PREVIOUSLY HAD HIGH IMPEDANCE WITH THE VNS IN (B)(6) 2010, WHICH WAS PREVIOUSLY REPORTED VIA MDR # 1644487-2010-02094. IT WAS SUGGESTED TO THE RPTR AT THAT TIME TO DISABLE THE VNS. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 200961 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male | Death |