BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 741639 · Received July 21, 2006

    Report

    Report Number
    1644487-2006-00262
    Event Type
    Malfunction
    Date Received
    July 21, 2006
    Report Date
    June 23, 2006
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER RECEIVED DEVICE-TRACKING INFORMATION INDICATING THAT THE PT UNDERWENT NCP SYSTEM REPLACEMENT SURGERY DUE TO LEAD DISCONTINUITY. FURTHER FOLLOW-UP WITH TREATING PHYSICIAN REVEALED THAT THE DEVICE DIAGNOSTIC TESTING AT OFFICE VISIT PRIOR TO NCP SYSTEM REPLACEMENT SURGERY RESULTED IN HIGH LEAD IMPEDANCE READING (SPECIFICS UNKNOWN), INDICATING POSSIBLE DEVICE MALFUNCTION. DURING THE NCP SYSTEM REPLACEMENT SURGERY, REPEAT DEVICE DIAGNOSTIC TESTING AFTER A REPLACEMENT, GENERATOR WAS CONNECTED TO THE ORIGINAL LEAD ALSO YIELDED HIGH LEAD IMPEDANCE TEST RESULT, INDICATING A PROBABLY LEAD FRACTURE. THE EXPLANTED DEVICES WERE DISCARDED AND WILL SUBSEQUENTLY NOT BE RETURNED TO MANUFACTURER FOR ANALYSIS. NO SERIOUS INJURY 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 34428C

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR EXPLANTED| PULSE GEN MODEL 102R, IMPLANTED