FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2211872
·
Received August 10, 2011
Report
- Report Number
- 1644487-2011-01831
- Event Type
- Malfunction
- Date Received
- August 10, 2011
- Date of Event
- June 1, 2011
- Report Date
- July 14, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A NEUROLOGIST VIA CLINIC NOTES THAT A VNS PT HAD BREAK-THROUGH SEIZURES BUT THE RELATIONSHIP OF THIS SEIZURE INCREASE IS NOT KNOWN TO PT'S PRE-VNS BASELINE. PT HAD A SENSATION OF "CLOSED THROAT" WHICH LASTED ABOUT 1 MINUTE, FOLLOWED BY COUGHING FOR ABOUT 2-3 MINUTES, AND ENDING WITH BURNING SENSATION IN HER THROAT WHICH STARTED IN (B)(6) 2011. PT'S GENERATOR INDICATED LOW BATTERY ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 014416 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR |