FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 1070428
·
Received July 3, 2008
Report
- Report Number
- 1644487-2008-01544
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- June 5, 2008
- Report Date
- June 5, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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 THAT AFTER REVIEW OF THE PT'S DEVICE DIAGNOSTIC HISTORY, HIGH IMPEDANCE HAD RESULTED FROM AN UNK TYPE OF DIAGNOSTIC TEST. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. ATTEMPTS TO OBTAIN ADD'L INFO FROM THE TREATING PHYSICIAN ARE UNDERWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 16617C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |