BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATIO

    MDR report key: 1592644 · Received January 22, 2010

    Report

    Report Number
    9610579-2010-00327
    Event Type
    Malfunction
    Date Received
    January 22, 2010
    Date of Event
    October 16, 2008
    Report Date
    October 21, 2008
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2010. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. METHOD: REVIEW OF THE ELECTRONIC DATA AND FILES REC'D. (B)(4). CONCLUSION: THE REPORTED BEHAVIOUR IS DUE OT A USER ERROR: NO PT NAME WAS ENTERED UPON ICD INTERROGATION. THEREFORE, PT FILES CREATED COULD NOT BE FOUND AFTERWARDS IN THE MGR SCREEN.

    Description of Event or Problem · 1

    THE ICD INVOLVED IN THIS MDR REPORT WAS INTERROGATED ON (B)(6) 2008 DURING SCHEDULED FOLLOW-UP. THE PHYSICIAN REPORTED THAT ALTHOUGH PT FILES HAVE BEEN STORED SEVERAL TIMES DURING THE SESSION, NO PT FILE RELATED TO THIS ICD APPEARED IN PT FILE LIST (IN THE MANAGER SCREEN). REPORTEDLY, PT FILES FROM OTHER OVARIO VR PTS HAVE BEEN STORED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVATIO MRM-DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN CRM VR 6250 S071122

    Patients

    Seq Age Sex Outcome Treatment
    1