BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSURA DR MRI SURESCAN

    MDR report key: 2790235 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02095
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    November 15, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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 TO A DEVICE MARKETED IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED AFTER THE USED BY DATE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSURA DR MRI SURESCAN IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. EN1DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other