BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 4192149 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05471
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    December 21, 2012
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    NVN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    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 COMPLAINT OF HIGH IMPEDANCE WAS NOT CONFIRMED IN THE LABORATORY. THE HELIX WAS RECEIVED IN THE RETRACTED POSITION AND CLOGGED WITH DRIED BODY FLUID AND TISSUE. AFTER CLEANING AND EXTENDING THE HELIX, IMPEDANCE MEASUREMENT WAS NORMAL. NO ANOMALY WAS FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED HIGH IMPEDANCE DURING IMPLANT. THE LEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31284 TENDRIL ST PERMANENT PACEMAKER ELECTRODE, NVN ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 1888TC/58

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR