FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2201315
·
Received August 3, 2011
Report
- Report Number
- 1644487-2011-01775
- Event Type
- Malfunction
- Date Received
- August 3, 2011
- Date of Event
- July 8, 2011
- Report Date
- July 8, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED A PT'S VNS GENERATOR WAS BELIEVED TO BE AT PREMATURE END OF SERVICE AND THE PT WAS ALSO EXPERIENCING AN INCREASE IN SEIZURES. THE PT HAD VNS GENERATOR REPLACEMENT PERFORMED, AND THE EXPLANTED GENERATOR HAS BEEN RETURNED AND IS PENDING ANALYSIS. A BATTERY LIFE ESTIMATE WITH AVAILABLE DATA YIELDED 0.97 YEARS REMAINING. ATTEMPTS FOR FURTHER INTO ARE IN PROGRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 200801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Required Intervention |