FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102R
MDR report key: 880060
·
Received July 13, 2007
Report
- Report Number
- 1644487-2007-00981
- Event Type
- Injury
- Date Received
- July 13, 2007
- Date of Event
- January 1, 2007
- Report Date
- June 14, 2007
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT, THE PT DEVELOPED AN EMPYEMA. THE PHYSICIAN STATED THAT, THE CAUSE IS UNKNOWN, BUT THAT THE EMPYEMA WAS POSSIBLY RELATED TO VNS THERAPY. IT WAS ALSO REPORTED THAT, THE PT HAS A "MEDICAL HISTORY OF VARIOUS EVENTS". THE VNS DEVICE HAS BEEN PROGRAMMED TO 0MA AS A RESULT OF THE EVENT, AND THE EMPYEMA HAS RESOLVED AFTER SURGICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102R | LYJ | CYBERONICS, INC. | 102R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |