FDA Adverse Event
Other
Summary report: N
PULSE GEN MODEL 101
MDR report key: 795085
·
Received December 7, 2006
Report
- Report Number
- 1644487-2006-00440
- Event Type
- Other
- Date Received
- December 7, 2006
- Date of Event
- January 1, 2006
- Report Date
- November 7, 2006
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THE NCP SYSTEM WAS EXPLANTED FOR TACHYCARDIA. SINCE EXPLANT, THE PT HAS NOT EXPERIENCED ANY MORE TACHYCARDIA. NO SERIOUS INJURY WAS REPORTED. NO FURTHER INFO IS AVAILABLE FROM THE REPORTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | LYJ | CYBERONICS, INC. | 101 | 3446 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other |