FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 1172603
·
Received September 19, 2008
Report
- Report Number
- 1644487-2008-02014
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- January 1, 2008
- Report Date
- July 30, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A VNS PATIENT RECEIVED A HIGH IMPEDANCE WARNING UPON DEVICE INTERROGATION. THE REPORTER ALSO INDICATED THAT AFTER THIS OFFICE VISIT THE PATIENT BEGAN TO EXPERIENCE AN INCREASE IN SEIZURES, BUT THE PATIENT'S MEDICATION HAD BEEN ADJUSTED AS WELL. THE PATIENT UNDERWENT REVISION SURGERY AND THE EXPLANTED LEAD AND GENERATOR WERE RETURNED TO THE MANUFACTURER, WHERE THEY ARE CURRENTLY AWAITING ANALYSIS. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 010657 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |