BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2850754 · Received November 23, 2012

    Report

    Report Number
    1000165971-2012-00457
    Event Type
    Injury
    Date Received
    November 23, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 12, 2012
    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). THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    CONNECTION AND ELECTRICAL ISSUES WERE REPORTED RELATIVE TO THE SUBJECT PACEMAKER. DURING THE IMPLANT PROCEDURE, THE SCREWDRIVER TURNED FREELY WHEN TIGHTENING THE VENTRICULAR SET-SCREW. THE SCREWDRIVER WAS TURNED COUNTERCLOCKWISE, THE SET-SCREW WAS TIGHTENED AGAIN AND CLICK SOUND WAS HEARD. THE CONNECTOR PIN WAS PROTRUDED FROM THE CONNECTOR BLOCK AND APPROPRIATE CONNECTION WAS CONFIRMED BY PULL TEST. WHEN THE DEVICE WAS STILL OUTSIDE THE POCKET IT WAS NOTED THAT SOME VENTRICULAR PACING SPIKES WERE MISSING (NOISE SUSPECTED). NORMAL MEASUREMENT VALUES WERE OBTAINED AT POST-IMPLANT CHECK. ON THE SAME DAY VENTRICULAR PACING FAILURE WAS NOTED ON THE ECG MONITOR AT THE HOSPITAL WARD. NO LEAD MIGRATION WAS CONFIRMED BY X-RAY. WHEN THE PACEMAKER WAS CHECKED, PACING AND SENSING FAILURE, LEAD IMPEDANCES ABOVE 3 KOHMS AT THE VENTRICULAR CHANNEL WERE CONFIRMED. A RE-INTERVENTION WAS SUBSEQUENTLY PERFORMED. WHEN THE PHYSICIAN PULLED THE VENTRICULAR LEAD BEFORE UNSCREWING THE SETSCREW, THE LEAD CAME OUT OF THE PORT. THIS ISSUE RECURRED THREE TIMES AFTER RE-INSERTING THE LEAD INTO THE PORT AND TIGHTENING IT WITH CLICK SOUND CONFIRMED. WHEN THE VENTRICULAR LEAD WAS MEASURED BY AN ANALYZER NORMAL VALUES WERE OBTAINED. THE LEAD WAS THEN INSERTED INTO THE ATRIAL PORT WITH AAI SETTINGS AND NO ANOMALIES WERE NOTED, APPROPRIATE VALUES WERE OBTAINED WHEN MEASURED BY THE PROGRAMMER. A NEW PACEMAKER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2637

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention