BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 4212853 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05092
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    June 24, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    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: INNER INSULATION DAMAGE WAS NOTED NEAR THE CONNECTOR, CAUSED BY OVER-TORQUE OF THE INNER COIL IN THE FIELD. THE INNER INSULATION DAMAGE CAUSED A SHORT BETWEEN THE COILS, WHICH IS CONSISTENT WITH THE FIELD OBSERVATION OF LOSS OF CAPTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE LEAD EXHIBITED LOSS OF CAPTURE. THE LEAD WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27752 TENDRIL ST PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC. CRMD 2088TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR