BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 1050460 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01441
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    July 3, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR AUTOCAPTURE WAS OVER- PACING AND THE LEAD WAS SUSPECTED TO BE THE ISSUE. LEAD IMPEDANCE WAS 256 OHMS IN UNIPOLAR AND 487 OHMS IN BIPOLAR. LEAD IMPEDANCE IN NOVEMBER 2007 WAS 304 OHMS IN UNIPOLAR. NO SENSING WAS OBSERVED IN THE BIPOLAR SENSING CONFIGURATION. VENTRICULAR AUTOCAPTURE WAS TURNED OFF AND THE DEVICE WAS PROGRAMMED TO THE UNIPOLAR SENSING CONFIGURATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION NOTES CAPTURE ANOMALY AND THE LEAD APPEARED IN AN ACUTE DISLODGED POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1688TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention