BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE RF

    MDR report key: 1073154 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02511
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 10, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 IMPLANT, HV LEAD IMPEDANCE WAS OUT OF RANGE. THE POCKET WAS REOPENED TO TIGHTEN DOWN THE LEAD INTO THE HEADER AND THE PROBLEM WAS RESOLVED. THE DEVICE AND LEAD REMAIN IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention