FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1021318
·
Received March 28, 2008
Report
- Report Number
- 1644487-2008-00784
- Event Type
- Injury
- Date Received
- March 28, 2008
- Date of Event
- February 1, 2008
- Report Date
- February 28, 2008
- 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 THE PT WAS EXPERIENCING AN INCREASE IN SEIZURES. IT IS NOT KNOWN IF THE INCREASE IS ABOVE OR BELOW PRE-VNS THERAPY BASELINE. GENERATOR HAD REPORTEDLY REACHED END OF SERVICE AND WAS REPLACED. GOOD FAITH ATTEMPTS WERE MADE WITH THE TREATING PHYSICIAN TO OBTAIN FURTHER INFO; HOWEVER, THESE ATTEMPTS WENT UNANSWERED. MOST LIKELY CAUSE OF THE INCREASE IN SEIZURES WAS DUE TO LOSS OF THERAPY SINCE GENERATOR HAD REACHED END OF SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 8185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |