BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATIO

    MDR report key: 2833438 · Received October 26, 2012

    Report

    Report Number
    9610579-2012-00102
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 9, 2012
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SUBJECT DEMO DEVICE WAS INTERROGATED IN ITS BOX BY THE SUBSIDIARY ON (B)(4) 2012. REPORTEDLY, A KNOWN PROGRAMMER SOFTWARE ISSUE (ATP SETTINGS ARE CHANGED WHEN "FIRST INTERROGATION" IN THE PRE-PROGRAMMED MODES IS CLICKED) HAS BEEN CORRECTED FOR OTHER MODELS, BUT IS STILL OBSERVED WITH THIS OVATIO ICD UPON INTERROGATION WITH 2.36J SOFTWARE VERSION. THE CUSTOMER REQUESTS A CORRECTION ALSO FOR OVATIO DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO MRM SORIN CRM OVATIO VR 6250

    Patients

    Seq Age Sex Outcome Treatment
    1