FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 1133584
·
Received August 19, 2008
Report
- Report Number
- 1644487-2008-01941
- Event Type
- Malfunction
- Date Received
- August 19, 2008
- Date of Event
- January 1, 2008
- Report Date
- July 22, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED TO THE MFR THAT THE VNS PT'S GENERATOR SHOWED HIGH LEAD IMPEDANCE DURING A DIAGNOSTIC TEST AND HAS ALSO BEEN EXPERIENCING AN INCREASE IN SEIZURE ACTIVITY. THE DEVICE WAS TURNED OFF SINCE A LEAD BREAK WAS SUSPECTED. THE PT WAS SENT FOR A SURGICAL CONSULT AND REPLACEMENT SURGERY IS PENDING FOR THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 1839 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |