BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTION

    MDR report key: 2130397 · Received June 16, 2011

    Report

    Report Number
    6000094-2011-01073
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    July 31, 2009
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT APPROPRIATELY MAKING MODE SWITCH HAPPEN IN CASE OF ATRIAL FIBRILLATION. THE DEVICE WAS REPROGRAMMED FROM DDDD MODE TO VVIR, AND REPROGRAMMED BACK TO DDDD MODE ONCE PATIENT WAS OUT OF ATRIAL FIBRILLATION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTION IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. 900E ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other