BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE RF

    MDR report key: 1073067 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02313
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 25, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE ANOMALY OBSERVED IN THE FIELD WAS VERIFIED BY TREND DATA RETRIEVED FROM THE DEVICE. IT WAS FOUND THAT THE DEVICE DID HAVE NORMAL HV LEAD IMPEDANCE WHEN TESTED. THE ANOMALY OBSERVED IN THE FIELD WAS NOT REPLICATED. THE CAUSE OF THE INTERMITTENT HV LEAD IMPEDANCE ANOMALY IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS REPLACED DUE TO LOW SHOCK IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMOTE RF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 3207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention