FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 730336
·
Received June 21, 2006
Report
- Report Number
- 1644487-2006-00228
- Event Type
- Malfunction
- Date Received
- June 21, 2006
- Report Date
- May 25, 2006
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT DEVICE DIAGNOSTIC TESTING (SYSTEMS DIAGNOSTICS) AT OFFICE VISIT RESULTED IN HIGH LOAD IMPEDANCE READING (DC-DC CODE 7 AND LIMIT), INDICATING POSSIBLE DEVICE MALFUNCTION. THE ELECTIVE REPLACEMENT INDICATOR WAS NO, RULING OUT GERNERATOR BATTERY END OF LIFE AS A LIKELY CAUSE OF THE HIG LEAD IMPEDANCE TEST RESULT. LEAD BREAK IS WAS REPORTED IN CONJUNCTION WITH THE HIGH LEAD IMPEDANCE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | LYJ | CYBERONICS, INC. | 300-20 | 14187C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | IMPLANT DATE| PULSE GEN MODEL 102R, S/N 1028768 |