BEUDAMED
    FDA Adverse Event Other Summary report: N

    TENDRIL SDX

    MDR report key: 3675712 · Received March 12, 2014

    Report

    Report Number
    2017865-2014-02590
    Event Type
    Other
    Date Received
    March 12, 2014
    Date of Event
    August 17, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 THE ATRIAL NOISE WAS DETECTED ON THE LEAD. SOME IMPEDANCE ANOMALY ALSO NOTED. THE LEAD WAS OPTED TO BE EXPLANTED AND REPLACED DURING DEVICE CHANGE OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146931 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC. CRMD 1688TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention