FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2160775
·
Received July 7, 2011
Report
- Report Number
- 1644487-2011-01524
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- January 7, 2011
- Report Date
- June 7, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA CLINIC NOTES RECEIVED THAT THE PATIENT HAD BEEN EXPERIENCING AN INCREASE IN SEIZURES AND CONDITION IS WORSE. IT IS NOTED THAT THE PATIENT ALSO HAS HAD A SINUS INFECTION AND THE FLU HOWEVER FOLLOW-UP WITH THE SITE FOR FURTHER INFORMATION HAS BEEN UNSUCCESSFUL TO DATE. THE PATIENT IS BEING REFERRED FOR PROPHYLACTIC GENERATOR REPLACEMENT BASED ON BATTERY LIFE CALCULATIONS. SURGERY HAS NOT OCCURRED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 11989 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Required Intervention |