BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 3925818 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15659
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    April 11, 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 RECEIVED WITH RETURN OF DEVICE. FAILURE EVENT OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND THAT A PARTIAL LEAD WAS RETURNED. THE LEAD INSULATION WAS ABRADED AT 3.3 CM TO 4.3 CM FROM THE CONNECTOR PIN WHICH EXPOSED THE COIL. THE ABRASION WAS CONSISTENT WITH EXPOSURE TO CONSTANT FRICTION WITH ANOTHER IMPLANTABLE DEVICE. RELIABILITY LABORATORY TECHNICIAN RELIABILITY LABORATORY TECHNICIAN ST. JUDE MEDICAL CRMD RELIABILITY LABORATORY

    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
    405008 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1688TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1