FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 1823591
·
Received August 27, 2010
Report
- Report Number
- 1644487-2010-01968
- Event Type
- Malfunction
- Date Received
- August 27, 2010
- Date of Event
- July 29, 2010
- Report Date
- July 29, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
INITIAL REPORTER INDICATED TO OUR CONSULTANT THAT THEY HAD A VNS PATIENT WHO HAD HIGH LEAD IMPEDANCE AND WOULD BE SCHEDULED FOR FULL REVISION SURGERY OF THEIR VNS. THE PATIENT HAD FULL REVISION SURGERY AND GOOD FAITH ATTEMPTS THUS FAR FOR ADDITIONAL DETAILS ABOUT THE EVENT AND PRODUCT FOR ANALYSIS HAVE BEEN UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 32266C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |