BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR ACTIVE FIXATION ENDOCARDIAL LEAD

    MDR report key: 2905381 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00459
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    November 15, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE PULSE GENERATOR CHANGE OUT, THE PHYSICIAN NOTED THAT ATRIAL LEAD INSULATION WAS ABRADED. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12701 BIPOLAR ACTIVE FIXATION ENDOCARDIAL LEAD PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1028T/56 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR (B)(4)