FDA Adverse Event
Malfunction
Summary report: N
BIPOLAR LEAD MODEL 300
MDR report key: 1872140
·
Received October 14, 2010
Report
- Report Number
- 1644487-2010-02297
- Event Type
- Malfunction
- Date Received
- October 14, 2010
- Date of Event
- September 14, 2010
- Report Date
- September 15, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- NURSE
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
A NEUROLOGY OFFICE REPORTED TO OUR COUNTRY REPRESENTATIVE THAT THEY HAD A VNS PATIENT WHO WAS HAVING LONGER AND INCREASED SEIZURES NOT ABOVE THEIR PREVNS BASELINE RATE. A SYSTEM DIAGNOSTIC TEST WAS PERFORMED AND SHOWED THE PATIENT TO HAVE HIGH LEAD IMPEDANCE. THE PATIENT'S TREATING PHYSICIAN'S OFFICE BELIEVES THE CAUSE OF THE PATIENT'S SEIZURES IS THEIR HIGH LEAD IMPEDANCE. THE PATIENT IS GOING TO BE SCHEDULED FOR REVISION SURGERY. NO DATE HAS BEEN SET AT THIS TIME. THE PATIENT'S VNS REMAINS PROGRAMMED ON. GOOD FAITH ATTEMPTS ARE UNDERWAY FOR FURTHER INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOLAR LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 5760 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR |