BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2031396 · Received March 23, 2011

    Report

    Report Number
    1000165971-2011-00125
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    January 4, 2011
    Report Date
    March 9, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, THE PT WAS DEFIBRILLATED BY AN EXTERNAL DEFIBRILLATOR. FOUR EXTERNAL SHOCKS WERE DELIVERED AND ABSENCE OF PACING PULSES WERE OBSERVED AFTER THE SECOND SHOCK. THE PACEMAKER WAS EXPLANTED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY SR 2360

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention