BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVL-ADX ACTIVE FIXATION LEAD

    MDR report key: 1051007 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01942
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    February 19, 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
    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 NOISE ON THE VENTRICULAR CHANNEL WAS OBSERVED ON THE DEVICE EGMS. THE DEVICE WAS REPROGRAMMED AND THE LEAD WILL BE MONITORED. CONTINUED NOISE ON THE VENTRICULAR CHANNEL WAS REPORTED ON 3/20/2008. THERAPIES WERE ABORTED. A LEAD FRACTURE WAS SUSPECTED. SENSE/PACE PORTION OF THE LEAD WAS CAPPED AND REPLACED.

    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 Required Intervention