BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 1896655 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04992
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 30, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE PROXIMAL INSULATION WAS ABRADED THROUGH TO THE COIL AT 9.3 CM TO 10.3 CM AND 26 CM FROM THE CONNECTOR PIN, DUE TO FRICTION WITH ANOTHER DEVICE.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER: DATE: "THIS WEEK", INRATIO: 5.3. "LAST WEEK", 4.6. PATIENT'S TARGET THERAPEUTIC RANGE IS 2.5 - 3.5. PATIENT HAS HYPOTHYROIDISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD EXHIBITED NOISE. INSPECTION REVEALED AN INSULATION BREAK.

    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/46

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention GUIDANT 0184 (B)(4)