BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR

    MDR report key: 2791442 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02205
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 8, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 WITHIN A FEW DAYS OF IMPLANT, A MISSING VENTRICULAR PACE WAS NOTED TWICE DURING A HOLTER MONITOR. THE DEVICE VENTRICULAR SENSITIVITY WAS REPROGRAMMED, AND 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 ADVISA DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. A5DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention