BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 2983685 · Received February 28, 2013

    Report

    Report Number
    2017865-2013-01447
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    November 13, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE PROXIMAL INSULATION WAS ABRADED AT 7.1 - 7.4 CM FROM THE CONNECTOR PIN. THE PROXIMAL COIL WAS EXPOSED IN THE SAME AREA WHICH COULD HAVE CONTRIBUTED TO THE NOISE PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD EXHIBITED AN INSULATION ANOMALY AND NOISE. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85913 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1688TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention