FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2032662
·
Received March 28, 2011
Report
- Report Number
- 1644487-2011-00647
- Event Type
- Death
- Date Received
- March 28, 2011
- Date of Event
- April 29, 2010
- Report Date
- February 26, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A VNS PT PASSED AWAY. PREVIOUSLY, THE PT HAD REPORTED AN INCREASE IN DEPRESSION AND WAS LOOKING FOR A VNS PHYSICIAN AS IT HAD BEEN SEVERAL YEARS SINCE THE LAST TIME HE HAD HIS VNS DEVICE CHECKED. THE INCREASED DEPRESSION WAS REPORTED IN MDR 1644487-2010-00388. THE PT MADE AN APPOINTMENT TO SEE A PHYSICIAN; HOWEVER, THE PT DID NOT MAKE THE APPOINTMENT NOR WAS THE APPOINTMENT RESCHEDULED. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THE PT'S DEATH ARE CURRENTLY BEING MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | MUZ | CYBERONICS, INC. | 102 | 015484 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Death |