BEUDAMED
    FDA Adverse Event Other Summary report: N

    TENDRIL SDX

    MDR report key: 3675693 · Received March 12, 2014

    Report

    Report Number
    2017865-2014-03543
    Event Type
    Other
    Date Received
    March 12, 2014
    Date of Event
    October 2, 2012
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ATRIAL LEAD EXHIBITED NOISE WITH OVERSENSING. THE LEAD REMAINED IMPLANTED AND WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147480 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, CRMD 1688T/52

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male