BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 1050474 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01275
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    February 2, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNIPOLAR LEAD IMPEDANCE WAS GREATER THAN 2000 OHMS, BIPOLAR R-WAVES WERE BETWEEN 1.8 AND 2.2 MV, AND NO CAPTURE WAS SEEN AT 4.5 V. A CHEST X-RAY SHOWED A LEAD FRACTURE. NO NOISE WAS SEEN WITH PACEMAKER POCKET MANIPULATION. A NEW SYSTEM WAS IMPLANTED AND THE CHRONIC SYSTEM WAS PROGRAMMED TO 45 PPM IN VVI MODE. THE OUTPUTS WERE LOWERED AS MUCH AS POSSIBLE. THE PATIENT WAS NOT PACEMAKER DEPENDENT.

    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 1488TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention