BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISA DR

    MDR report key: 2123946 · Received June 14, 2011

    Report

    Report Number
    6000094-2011-00749
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    February 28, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANT, THE PATIENT WAS MONITORED FOR 24 HOURS PER (B)(4). THE MONITOR INDICATED A BLOCKED P-WAVE, RESULTING IN A LOSS OF VENTRICULAR STIMULATION, AND THE PATIENT EXPERIENCED AN EPISODE. THE PATIENT WAS MONITORED ONCE AGAIN, AND ALL MEASUREMENTS WERE FINE. THE PATIENT WILL CONTINUE TO BE MONITORED WITH A HOLTER MONITOR, AND THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVISA DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. A3DR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other