BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION LEAD

    MDR report key: 1050851 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01798
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    March 17, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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 POST-SENSED T-WAVE OVERSENSING ON THE VENTRICULAR LEAD WAS OBSERVED. NOISE ON THE LEAD INDICATES A POTENTIAL FRACTURE OF THE CONDUCTOR. THE DEVICE WAS REPROGRAMMED. THE SYSTEM REMAINS IMPLANTED AND THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1