BEUDAMED
    FDA Adverse Event Summary report: N

    UNIFY CRT-D, DF-4 CONNECTOR

    MDR report key: 1896059 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04723
    Date Received
    November 10, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED NOISE WAS NOT VERIFIED IN THE LABORATORY. DURING ANALYSIS A CARDIAC SIMULATOR WAS CONNECTED TO THE DEVICE. THE DEVICE SENSED THE CARDIAC SIGNALS PROPERLY. AN HVLIC WAS PERFORMED AND NO NOISE WAS OBSERVED ON THE REAL- TIME EGM. THE DEVICE PACED NORMALLY DURING THE MEASUREMENTS, AND THERE WAS NO PACING INHIBITION. THE DEVICE WAS TESTED ON THE BENCH AND ON THE AUTOMATED ELECTRICAL SYSTEM. ALL DEVICE FUNCTIONS WERE NORMAL. IT IS NOT KNOWN WHAT CAUSED THE NOISE OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS NOTICED WHEN INITIATING THE (B)(6) . THE DEVICE OVERSENSED NOISE AND INHIBITED PACING. NOISE WAS PRESENT ON ALL CHANNELS. A CONNECTION ISSUE WAS SUSPECTED. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIFY CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3231-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)