BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 4143241 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05708
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    May 14, 2012
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MFR, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXHIBITED NOISE ON THE ATRIAL LEAD. THE DEVICE REMAINED IMPLANTED WHILE THE REP CONTACTED THE PHYSICIAN FOR A DECISION MOVING FORWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31560 TENDRIL STS PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 2088TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR