BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATIO

    MDR report key: 1831958 · Received September 7, 2010

    Report

    Report Number
    9610579-2010-00584
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 22, 2010
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2010. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING THE FOLLOW-UP OF THE DEVICE INVOLVED IN THIS MDR REPORT, AN EPISODE RECORDED IN DEVICE MEMORIES SHOWED AN ATP THERAPY WHICH WAS DELIVERED SUCCESSFULLY, DESPITE NO ATP THERAPY WAS PROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO MRM SORIN CRM OVATIO DR 6550 S070110

    Patients

    Seq Age Sex Outcome Treatment
    1