BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 4121459 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-07768
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    August 15, 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
    GA, US
    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.

    Description of Event or Problem · 1

    NEW INFORMATION INDICATES THE LEAD CONTINUES TO EXHIBIT CAPTURE ANOMALY. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD WAS EXHIBITING LOW IMPEDANCE AND LOSS OF CAPTURE AT HIGH OUTPUTS WITH POOR SENSING. THE PATIENT WAS NOT FEELING WELL. THE DEVICE WAS REPROGRAMMED TO VVI AND THE PATIENT CONDITION IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32295 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE, NVN NVN ST. JUDE MEDICAL, INC., CRMD 1488T/46

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention