BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION LEAD

    MDR report key: 3881155 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02196
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    November 11, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS REC'D. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE F/U, HIGH VOLTAGE IMPEDANCE WAS NOTED. TWO DAYS LATER, THE PATIENT WAS HOSPITALIZED DUE TO A VIBRATIONAL ALERT INDICATING OUT OF RANGE IMPEDANCE. THE DEVICE WAS REPROGRAMMED TO NOMINAL VALUES AND REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27835 RIATA PASSIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D 1570/65

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention