BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2821039 · Received October 26, 2012

    Report

    Report Number
    1000165971-2012-00411
    Event Type
    Injury
    Date Received
    October 26, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 18, 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) 2012. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    INTERROGATION FAILURE OF THE SUBJECT DEVICE WAS REPORTED AFTER THE APPLICATION AN EXTERNAL DEFIBRILLATION SHOCK (50J) TO TERMINATE ATRIAL FIBRILLATION. IT WAS INDICATED THAT THE DEFIBRILLATION PATCH WAS PLACED BETWEEN 1 AND 2CM FORM THE PACEMAKER. ANOTHER PACEMAKER WAS IMPLANTED 2 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2342

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention