BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 1800919 · Received August 10, 2010

    Report

    Report Number
    1000165971-2010-00857
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 21, 2010
    Manufacturer
    SORIN BIOMEDICA 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

    REPORTEDLY, A HIGH VENTRICULAR IMPEDANCE (OVER 3000 OHMS) WAS MEASURED DURING THE FOLLOW-UP ONE WEEK AFTER IMPLANTATION; IN ADDITION, PACING FAILURE WAS OBSERVED AT THE HIGHEST OUTPUT FROM THE PACEMAKER, AND THE R WAVE AMPLITUDE WENT DOWN FROM 7-8MV (AS MEASURED AT IMPLANT) TO 2-3MV. AN X-RAY WAS TAKEN, WHICH REVEALED THAT THE TIP OF THE LEAD CONNECTOR PIN WAS COMING OUT SLIGHTLY FROM THE PACEMAKER CONNECTOR PORT. THEREFORE A REINTERVENTION WAS CARRIED OUT: THE LEAD WAS CONFIRMED TO BE FIXED WITHIN THE PACEMAKER PORT BY A PULL TEST; THEREFORE, THE SETSCREW WAS UNSCREWED IN ORDER TO TAKE THE LEAD OUT FROM THE PORT. A PSA WAS UTILIZED TO OBTAIN THE LEAD MEASUREMENTS, WHICH REVEALED NO ABNORMAL RESULT. A NEW PACEMAKER WAS SUCCESSFULLY IMPLANTED. 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 BIOMEDICA C.R.M., S.R.L. REPLY DR 2435

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention