BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 4193567 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04167
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    July 17, 2012
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. EVALUATION DESCRIPTION: THE REPORTED FIELD EVENT OF LOSS OF CAPTURE AND LOSS OF SENSING WAS VERIFIED IN THE LABORATORY. TOO MANY REVOLUTIONS WHEN TRYING TO EXTEND THE HELIX CAUSED THE INNER COIL TO BECOME OVER TORQUE AND THIS DAMAGED THE INNER INSULATION AND SHORT CIRCUITED THE LEAD COILS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED LOSS OF CAPTURE AND LOSS OF SENSING DURING IMPLANT. THE LEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29564 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, CRMD 1882TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1