BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 4212794 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05062
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    July 15, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    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. NORMAL ANALYSIS. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH OUT OF RANGE IMPEDANCE WAS OBSERVED ON THE RIGHT VENTRICULAR LEAD IN UNIPOLAR CONFIGURATION DURING IMPLANT. NO PSA MEASUREMENTS COULD BE OBTAINED IN BIPOLAR CONFIGURATION. THE LEAD WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27747 TENDRIL ST PERMANENT PACEMAKER ELECTRODE, DTB DTB ST. JUDE MEDICAL, INC., CRMD 1888TC/58

    Patients

    Seq Age Sex Outcome Treatment
    1