BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATIO

    MDR report key: 2833457 · Received October 26, 2012

    Report

    Report Number
    9610579-2012-00104
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 15, 2012
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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

    REPORTEDLY, DURING A SCHEDULED FOLLOW-UP ON (B)(6) 2012, A WARNING RESET STATING THAT THE DEVICE WAS RE-INITIALIZED TWICE WAS DISPLAYED. THE LAST RESET WAS DATED (B)(6) 2012. IT WAS SUSPECTED THAT BOTH RE-INITIALIZATIONS HAD OCCURRED DURING THE FOLLOW-UP. AN EXPLANTATION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO MRM SORIN CRM OVATIO DR 6550 S080313

    Patients

    Seq Age Sex Outcome Treatment
    1