BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 1050860 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01312
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    February 3, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 SENSING WAS AT 0.3 MV. WHEN THE RATE WAS INCREASED, THE PATIENT'S ATRIUM BECAME ACTIVE, BUT THERE WAS NO SENSING. CAPTURE TESTING WAS UNAVAILABLE IN AOO AND AAI MODES AT MAXIMUM OUTPUT. MICRODISLODGEMENT OF THE ATRIAL J LEAD WAS SUSPECTED. ANTERIOR-POSTERIOR X-RAYS CONFIRMED THAT THE ATRIAL LEAD WAS STRAIGHT, WITH NO J SHAPE IN THE SUPERIOR VENA CAVA OR THE LOWER ATRIAL APPENDAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1688TC/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1