BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR ACTIVE FIXATION ENDOCARDIAL LEAD

    MDR report key: 2983787 · Received February 28, 2013

    Report

    Report Number
    2017865-2013-01339
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    December 17, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 THE ATRIAL LEAD EXHIBITED ELECTRICAL ISSUES THAT RESULTED FROM AN INSULATION ANOMALY. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89050 BIPOLAR ACTIVE FIXATION ENDOCARDIAL LEAD PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1028T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention