BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2040922 · Received March 25, 2011

    Report

    Report Number
    1000165971-2011-00127
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 8, 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

    MARCH 25, 2011, THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING CONNECTION OF THE VENTRICULAR LEAD AT IMPLANT COMPLETE INSERTION WAS REPORTED BY THE PHYSICIAN. THE SET-SCREW WAS TIGHTENED WITH THE SCREWDRIVER, AND THE CLICK SOUND WAS CONFIRMED ALONG WITH "ONE VENTRICULAR PACING". THEN BOTH ATRIAL AND VENTRICULAR SENSING WERE OBSERVED AFTERWARD. THE PACEMAKER WAS THEN IMPLANTED. DURING POST-IMPLANT FOLLOW-UP, PACING AND SENSING FAILURE WERE IDENTIFIED IN THE VENTRICULAR CHAMBER, AND IMPEDANCE WAS >3000 OHMS. RE-PROGRAMMING TO UNI-POLAR SETTING DID NOT RESOLVE THE ISSUE. THE POCKET WAS OPENED, AND THE PACEMAKER AND THE VENTRICULAR LEAD WERE CHECKED. REPORTEDLY, THE VENTRICULAR LEAD WAS NOT COMPLETELY INSERTED INTO THE PORT. THE SET-SCREW WAS LOOSENED WITH ONE TURN, AND THEN THE VENTRICULAR LEAD WAS RE-CONNECTED. THE PHYSICIAN TURNED THE SCREWDRIVER UNTIL CLICK SOUND WAS CONFIRMED. THE LEAD PULL TEST CONFIRMED THAT THE LEAD WAS NOT CONNECTED. THIS WAS REPEATED WITH ANOTHER SCREWDRIVER WITH THE SAME RESULTS. ANOTHER PACEMAKER WAS SUBSEQUENTLY IMPLANTED. THE PHYSICIAN HAS WATCHED THE ASSOCIATED VIDEO POSTED ON THE COMPANY WEBSITE, AND AS INDICATED, THE RECOMMENDED METHODS WERE APPLIED.

    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