FDA Adverse Event
Other
Summary report: N
PULSE GEN MODEL 102
MDR report key: 842100
·
Received April 25, 2007
Report
- Report Number
- 1644487-2007-00427
- Event Type
- Other
- Date Received
- April 25, 2007
- Date of Event
- November 21, 2006
- Report Date
- December 18, 2006
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CAUSE AND CIRCUMSTANCES OF THE PATIENT'S DEATH IS UNKNOWN.
Description of Event or Problem · 1
REPORTER INDICATED A VNS PATIENT HAD "EXPIRED" APPROX ONE AND A HALF MONTHS POST IMPLANT. THE CAUSE OF DEATH WAS UNKNOWN, WHEN INITIAL REPORT WAS RECEIVED BY MANUFACTURER. ATTEMPTS TO GATHER ADDITIONAL INFO FROM IMPLANTING SURGEON HAVE BEEN UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 014714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |