FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 105
MDR report key: 3973002
·
Received August 1, 2014
Report
- Report Number
- 1644487-2014-01916
- Event Type
- Malfunction
- Date Received
- August 1, 2014
- Date of Event
- July 6, 2014
- Report Date
- July 6, 2014
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS HAVING A RECENT INCREASE IN SEIZURE ACTIVITY. THE PHYSICIAN REPORTED THAT THE RECENT DIAGNOSTICS RESULTS ARE "STABLE". THERE HAVE BEEN NO INTERVENTIONS TAKEN. THE PHYSICIAN REPORTED THAT THE MOST LIKELY CAUSE OF THE INCREASE IN SEIZURES IS EXTERNAL FACTORS. IT IS UNKNOWN IF THE INCREASE IN SEIZURES IS ABOVE THE PATIENT'S PRE-VNS BASELINE FREQUENCY. AN MRI WAS PERFORMED AND SHOWED NO CHANGE THAT MAY HAVE CONTRIBUTED TO THE INCREASE IN SEIZURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 450056 | PULSE GEN MODEL 105 | GENERATOR | LYJ | CYBERONICS INC | 105 | 3184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR |