BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATIO

    MDR report key: 2945453 · Received February 1, 2013

    Report

    Report Number
    9610579-2013-00005
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    November 26, 2012
    Report Date
    January 15, 2013
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013: THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING DEVICE FOLLOW-UP, EPISODES STORED IN DEVICE MEMORY WERE REVIEWED. FOR SOME OF THEM, THE DELIVERED THERAPY (EITHER SHOCK OR ATP) WAS CONSIDERED AS INAPPROPRIATE. CONSEQUENTLY, DEVICE SETTINGS WERE MODIFIED TO AVOID INAPPROPRIATE THERAPIES IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43776 OVATIO MRM SORIN CRM OVATIO DR 6550 S090710

    Patients

    Seq Age Sex Outcome Treatment
    1