BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TVL-ADX ACTIVE FIXATION LEAD

    MDR report key: 1050843 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01789
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    March 24, 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
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    LOW PACING LEAD IMPEDANCE WAS REPORTED. NO ACTIONS WILL BE TAKEN AT THIS TIME 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