BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR VENTRICULAR ENDOCARDIAL LEAD

    MDR report key: 3923218 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14532
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 4, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE EVENT OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND THAT THE LEAD WAS RECEIVED IN TWO PIECES. INSULATION WAS ABRADED AT 5.9 TO 6.2CM FROM THE CONNECTOR PIN. ON THE SECOND PIECE, INSULATION ABRASIONS WERE FOUND AT 62.8 TO 63.0CM, 68.4 TO 69.6CM, AND 68.6 TO 69.8CM FROM THE CUT END. THE ABRASIONS WERE CONSISTENT WITH CONSTANT FRICTION WITH ANOTHER DEVICE OR HEART FEATURE.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401982 BIPOLAR VENTRICULAR ENDOCARDIAL LEAD PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1226T/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1