BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TVL-ADX ACTIVE FIXATION LEAD

    MDR report key: 1073044 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02294
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    April 29, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH HV LEAD IMPEDANCE WAS OBSERVED. ALL OTHER VALUES WERE NORMAL. NO NOISE WAS OBSERVED. THE LEAD REMAINS IMPLANTED AND THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TVL-ADX ACTIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1559/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1