FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 103
MDR report key: 4103316
·
Received September 19, 2014
Report
- Report Number
- 1644487-2014-02415
- Event Type
- Injury
- Date Received
- September 19, 2014
- Date of Event
- March 5, 2014
- Report Date
- August 22, 2014
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
CLINIC NOTES DATED (B)(6) 2014 NOTE THAT THE PATIENT FEELS THAT THE INTENSITY OF HER SEIZURES ARE WORSE DESPITE THE INCREASE IN VIMPAT. IT IS UNKNOWN IF THE INCREASE IN INTENSITY IS ABOVE PRE-VNS BASELINE FREQUENCY. CLINIC NOTES DATED (B)(6) 2014 NOTE THAT THE PATIENT'S MOTHER FEELS THAT OVER THE LAST WEEK OR SO THERE HAS BEEN SLIGHTLY LESS SEIZURE ACTIVITY. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT¿S INCREASE IN SEIZURE INTENSITY WAS BELIEVED TO BE DUE TO MEDICATION CHANGES. THE PATIENT¿S DEVICE WAS FUNCTIONING AS INTENDED AND UNRELATED TO THE CHANGE IN SEIZURE INTENSITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584955 | PULSE GEN MODEL 103 | GENERATOR | LYJ | CYBERONICS, INC. | 103 | 3227 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Required Intervention |