BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 3926187 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15496
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    April 8, 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. EVALUATION DESCRIPTION: NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE EVENT OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND THAT AN INCOMPLETE LEAD WAS RETURNED. INSULATION ABRASIONS WERE NOTED NEAR THE DISTAL TIP AND AT THE PROXIMAL END OF THE LEAD. THE ABRASIONS WERE CONSISTENT WITH CONSTANT FRICTION TO ANOTHER IMPLANTABLE DEVICE. (B)(6).

    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
    402714 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1688TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1