BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2850549 · Received November 16, 2012

    Report

    Report Number
    1000165971-2012-00444
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 7, 2012
    Manufacturer
    SORIN C.R.M., S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    ELECTRICAL PROBLEMS WERE REPORTED TO THE SUBJECT PACEMAKER DURING A ONE WEEK POST-IMPLANT F/U. REPORTEDLY, THE VENTRICULAR LEAD IMPEDANCE WAS ABOVE 3 KOHM. THE THRESHOLD AND R WAVE AMPLITUDE COULD NOT BE MEASURED. CAPTURE FAILURE WAS ALSO OBSERVED AT 7.5V/1.0 MS IN BIPOLAR AND UNIPOLAR CONFIGURATION. THE DEVICE WAS PROGRAMMED FROM DDD TO AAI MODE. A PACEMAKER REVISION WAS PERFORMED FIVE DAYS AFTER. THE CONNECTOR PIN OF THE VENTRICULAR LEAD WAS CONFIRMED TO BE PROTRUDED FROM THE CONNECTOR BLOCK BY X-RAY. THE DEVICE AND THE LEADS WERE EXPLANTED FROM THE POCKET, A PULL TEST WAS PERFORMED AND THE VENTRICULAR LEAD WAS CONFIRMED TO BE CONNECTED TO THE PORT. THE LEAD WAS DISCONNECTED, MEASURED BY AN ANALYZER AND NORMAL VALUES WERE OBTAINED. A NEW PACEMAKER WAS IMPLANTED. PACING IN THE VENTRICULAR CHANNEL WAS CONFIRMED AFTER TIGHTENING THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN C.R.M., S.R.L. REPLY DR 2631

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention