FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 1188717
·
Received October 2, 2008
Report
- Report Number
- 1644487-2008-02390
- Event Type
- Malfunction
- Date Received
- October 2, 2008
- Date of Event
- January 1, 2008
- Report Date
- September 4, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- 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
REPORTER INDICATED THAT THE PATIENT'S VNS DEVICE WAS INTERROGATED ON (B) (6) 2008 AND SHOWED HIGH IMPEDANCE. PER DOCTOR, DEVICE WAS TURNED OFF. ALL ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | NONE | LYJ | CYBERONICS, INC. | 300-20 | 3536 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR |