BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 4121624 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-07668
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    December 13, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 INITIAL REPORTER: COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED LOW LEAD IMPEDANCE. THE LEAD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32210 TENDRIL ST PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC. CRMD 1888TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR