FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 105
MDR report key: 4163487
·
Received October 10, 2014
Report
- Report Number
- 1644487-2014-02638
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- May 6, 2014
- Report Date
- September 12, 2014
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ADDITIONAL PRODUCT INFORMATION WAS RECEIVED.
Description of Event or Problem · 1
INITIALLY, IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO TOLERATE AN INCREASE IN OUTPUT CURRENT TO 0.5MA AFTER GENERATOR AND LEAD REPLACEMENT. IT WAS REPORTED THAT DEVICE DIAGNOSTICS WERE WITHIN NORMAL LIMITS. IT WAS LATER REPORTED THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES AND WOULD BE SENT FOR AN EEG AND CT. IT IS UNKNOWN IF THE PATIENT'S SEIZURES ARE AN INCREASE ABOVE THE PATIENT'S PRE-VNS BASELINE FREQUENCY. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 639731 | PULSE GEN MODEL 105 | GENERATOR | LYJ | CYBERONICS, INC. | 105 | 202614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR |