BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 4193301 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04396
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    June 21, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 FIELD EVENT OF LOSS OF SENSING WAS NOT CONFIRMED IN THE LABORATORY. ELECTRICAL MEASUREMENTS REVEALED HIGH IMPEDANCE DUE TO THAT THE HELIX WAS IN RETRACTED POSITION AND WAS CLOGGED WITH DRIED BODY FLUID/TISSUE. NORMAL LEAD IMPEDANCE WAS MEASURED WHEN HELIX WAS IN EXTENDED POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT THE LEAD EXHIBITED LOSS OF SENSING. THE LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28053 TENDRIL STS PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 2088TC/58

    Patients

    Seq Age Sex Outcome Treatment
    1