BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATIO

    MDR report key: 2093301 · Received April 15, 2011

    Report

    Report Number
    9610579-2011-00032
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 31, 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), 2001: THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING A PLANNED FOLLOW-UP ON (B)(6) 2011, THE PHYSICIAN OBSERVED NOISE OVERSENSING ON AN EPISODE LABELLED AS "VF" (VENTRICULAR FIBRILLATION); THIS NOISE PHENOMENON SEEMS TO BE NOT REPRODUCIBLE DURING THE FOLLOW-UP. THE PHYSICIAN IS ASKING FOR ANALYSIS AND SUGGESTIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1