BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 4212897 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05086
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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 LEAD FAILURE COULD NOT BE CONFIRMED IN THE LABORATORY. ANALYSIS FOUND SQUEEZED OUTER COIL AT 19.5 CM FROM THE CONNECTOR PIN THAT ALSO RESULTED DAMAGED INNER INSULATION. SHORT CIRCUIT WAS MEASURED BETWEEN SENSING AND PACING COIL DUE TO DAMAGED INNER INSULATION. THE DAMAGE FOUND ON THE LEAD WAS CONSISTENT WITH THAT OCCURRED IN THE FIELD DURING IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAD EXHIBITED CAPTURE ANOMALIES AT THE END OF THE IMPLANT PROCEDURE. A NEW LEAD WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29326 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC. CRMD 1888TC/58

    Patients

    Seq Age Sex Outcome Treatment
    1