BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 3925810 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15651
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    April 4, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.NO COMPLAINT WAS RECEIVED WITH THE RETURN OF DEVICE. FAILURE WAS OBSERVED DURING ANALYSIS.FINAL ANALYSIS FOUND THAT A PARTIAL LEAD WAS RETURNED. AN INSULATION ABRASION WAS FOUND EXPOSING THE OUTER COIL. ABRASION ARE CONSISTENT WITH EXPOSURE TO CONSTANT FRICTION WITH ANOTHER IMPLANTABLE DEVICE.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404019 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1688TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1