BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATIO

    MDR report key: 1883082 · Received October 15, 2010

    Report

    Report Number
    9610579-2010-00603
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 4, 2010
    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

    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 LAST PLANNED FOLLOW-UP ON (B)(6), 2010, THE SAFER PACING MODE WAS NOT LISTED IN THE AVAILABLE PROGRAMMABLE MODES WITH THE PROGRAMMER WHEN THE ICD INVOLVED IN THIS MDR REPORT WAS INTERROGATED; IN ADDITION, THE PHYSICIAN REQUESTED EXPLANATIONS ABOUT UNEXPECTED MARKERS VISIBLE IN STORED EPISODE (SUCH AS BIV MARKERS, INTENDED FOR CRT DEVICE, WHILE THE OVATIO INVOLVED IN THIS REPORT WAS A DR MODEL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO MRM SORIN CRM OVATIO DR 6550 S080812

    Patients

    Seq Age Sex Outcome Treatment
    1