BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 4192267 · Received January 11, 2014

    Report

    Report Number
    2017865-2014-02184
    Event Type
    Malfunction
    Date Received
    January 11, 2014
    Date of Event
    January 28, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE LEAD EXHIBITED A HIGH CAPTURE THRESHOLD WHEN CONNECTED TO THE PACEMAKER. THE LEAD WAS PLUGGED INTO A NEW DEVICE AND THERE WAS STILL HIGH THRESHOLDS. AFTER LEAD REPOSITIONING, THERE WAS NO GOOD R-WAVES OR ADEQUATE THRESHOLDS. CLAVICULAR CRUSH WAS REPORTED ON THE LEAD. THE LEAD WERE EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22181 TENDRIL STS PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 2088TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR PM 2210, 7194378