BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 1991102 · Received February 11, 2011

    Report

    Report Number
    1000165971-2011-00069
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 24, 2011
    Manufacturer
    SORIN CRM 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), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MFR AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE IMPLANTATION PROCEDURE, THE LEADS WERE TESTED THEN CONNECTED INTO THEIR CORRESPONDING PACEMAKER PORTS. WHEN THEY WERE CONNECTED, THE SCREWDRIVER CLICKING SOUNDS WERE CONFIRMED AT EACH SIDE RESPECTIVELY, AND EACH LEAD WAS CONFIRMED TO BE FIXED WITHIN THE PORT WHEN PULL TESTS WERE APPLIED. THE POCKET SUTURE WAS STARTED ONCE THE VENTRICULAR PACING SPIKES WERE CONFIRMED ON ECG MONITOR; HOWEVER, THE VENTRICULAR PACING SPIKES BECAME INTERMITTENT WHILE THE POCKET WAS BEING SUTURED. AFTER THE POCKET WAS SUTURED COMPLETELY, THE VENTRICULAR LEAD IMPEDANCE WAS MEASURED ON THE PROGRAMMER, WHICH REVEALED TO BE HIGH (3000 OHMS). THE PACEMAKER WAS EXTRACTED AGAIN FROM THE POCKET, AND THE LEAD WAS RECONNECTED INTO ITS CORRESPONDING PACEMAKER PORT; HOWEVER, PACING SPIKES COULD NOT BE CONFIRMED. A NEW PACEMAKER WAS IMPLANTED INSTEAD AND THE IMPLANTATION PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ANOMALY. THE PACEMAKER INVOLVED IN THIS MDR REPORT WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2488

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention