BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATIO

    MDR report key: 1800931 · Received August 10, 2010

    Report

    Report Number
    9610579-2010-00573
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    October 3, 2009
    Report Date
    July 26, 2010
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    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

    REPORTEDLY, THE ICD INVOLVED IN THIS MDR REPORT COULD NOT BE INTERROGATED AFTER SHOCK THERAPY DELIVERY. THE DEVICE WAS EXPLANTED THE DAY FOLLOWING THE IMPLANTATION AND WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO MRM SORIN CRM OVATIO VR 6250 S090626

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention