BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 4133717 · Received October 1, 2014

    Report

    Report Number
    2938836-2014-16288
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    March 26, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 20.3CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 17.4-17.9CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE DEVICE CAN. THE ETFE COATING WAS INTACT AT THIS LOCATION.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED STATES THAT RIGHT VENTRICULAR LOSS OF CAPTURE WAS OBSERVED. THE LEAD WILL STILL BE REPLACED DURING DEVICE CHANGE-OUT.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED STATES THE LEAD WAS CAPPED AND REPLACED DURING ICD REPLACEMENT FOR NORMAL ERI. THE NEW LEAD FUNCTIONED WELL AND NO ISSUES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE ASYMPTOMATIC PATIENT PRESENTED IN-CLINIC FOR A ROUTINE CHECKUP, INTERROGATION REVEALED HIGH, OUT OF RANGE PACING LEAD IMPEDANCE. THE IMPEDANCE HAD BEEN GRADUALLY INCREASING. THE LEAD WILL BE REPLACED WHEN THE DEVICE WILL BE CHANGED OUT. PATIENT WILL BE FOLLOWED-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611633 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7000/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR