BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 4202257 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04985
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    November 15, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    NVN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. 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. EVAL: THE REPORTED FIELD COMPLAINTS FOR CAPTURE, SENSING AND NOISE WERE CONFIRMED IN THE LABORATORY. SUTURE SLEEVE TIE DOWN DAMAGE WAS NOTED AT THE PROXIMAL END AND THE OUTER COIL AND INNER INSULATION WERE DAMAGED. THIS COULD HAVE CONTRIBUTED TO THE CAPTURE AND SENSING REPORTED. OTHER DAMAGES FOUND ON LEAD ARE CONSISTENT WITH THAT OCCURRING AT THE TIME OF THE EXPLANT. THE LEAD WAS OTHERWISE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE RIGHT VENTRICULAR LEAD EXPERIENCED LOSS OF CAPTURE, LOSS OF SENSING, NOISE, OVERSENSING AND HIGH IMPEDANCE. THE LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29058 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI 1688TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR