BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 1830983 · Received September 7, 2010

    Report

    Report Number
    1000165971-2010-00889
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 26, 2010
    Manufacturer
    SORIN BIOMEDICA 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

    ON 09/07/2010: THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, ONE WEEK AFTER IMPLANTATION OF THE PACEMAKER INVOLVED IN THIS MDR REPORT, INTERMITTENT PACING FAILURE WAS OBSERVED. DURING THE RE-INTERVENTION, A PULL TEST WAS CARRIED OUT ON THE VENTRICULAR LEAD AFTER THE PACEMAKER WAS TAKEN OUT FROM THE POCKET, AND THE LEAD WAS PULLED OUT FROM THE PORT EASILY EVEN THOUGH THERE WERE SOME SLIGHT RESISTANCES. THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. ANOTHER PACEMAKER WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA CRM S.R.L. REPLY DR 2446

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention