BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIA DR-T

    MDR report key: 2860689 · Received October 29, 2012

    Report

    Report Number
    1028232-2012-02678
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG.
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER THE POCKET WAS CLOSED, HIGH IMPEDANCES AND LOSS OF CAPTURE WERE NOTED ON THE ATRIAL CHANNEL. THE PHYSICIAN REOPENED THE POCKET, TESTED BOTH LEADS WITH PSA AND THE MEASUREMENTS WERE NORMAL. THE LEADS WERE RECONNECTED TOT HE DEVICE AND THE RA LEAD WAS OUT OF RANGE AGAIN. THE PHYSICIAN THEN CONNECTED THE RV LEAD TO THE RA PORT AND NOTED HIGH IMPEDANCES ON THE RV LEAD. THEN BOTH LEADS WERE RECONNECTED TO THE CORRECT PORTS AND BOTH LEADS EXHIBITED HIGH IMPEDANCES. AT THIS TIME, THE PHYSICIAN REQUESTED A NEW DEVICE. WITH THE NEW DEVICE, BOTH LEAD HAD NORMAL IMPEDANCES AND GOOD CAPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVIA DR-T PACER LEAD NVZ BIOTRONIK SE & CO. KG. 359529

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization