BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATIO

    MDR report key: 2182869 · Received July 8, 2011

    Report

    Report Number
    9610579-2011-00071
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 28, 2011
    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), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY ON (B)(6) 2011, THE PHYSICIAN OBSERVED THAT THE ICD INVOLVED IN THIS MDR WAS PROGRAMMED WITH NOMINAL PARAMETERS. IN ADDITION, HE OBSERVED THAT A FILE CORRESPONDING TO DEVICE RE-INITIALIZATION WAS RECORDED ON THE ORCHESTRA. THE PHYSICIAN WANTS AN EXPLANATION ABOUT THE REPORTED BEHAVIOR.

    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