BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATIO

    MDR report key: 2002493 · Received January 28, 2011

    Report

    Report Number
    9610579-2011-00006
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 19, 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: NO SENSING VALUE WERE DISPLAYED WHEN PERFORMING AN ATRIAL SENSING TEST. THE ATRIAL STATISTICS WERE INCONSISTENT (18.000 ATRIAL EVENTS VS. 22.000.000 VENTRICULAR EVENTS). THE PHYSICIAN REQUESTED AN EXPLANATION OF THE REPORTED BEHAVIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO MRM SORIN CRM OVATIO DR 6550 M071026

    Patients

    Seq Age Sex Outcome Treatment
    1