BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO DR

    MDR report key: 2790646 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02265
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 15, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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/SIMILAR TO A DEVICE MARKETED IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE FOLLOW UP VISIT, IT WAS NOT POSSIBLE TO ACCESS DATA FOR A TREATED VENTRICULAR TACHYCARDIA EPISODE. THIS IS A KNOWN ISSUE IN THE FIRMWARE WITHIN THE DEVICE WHICH CAUSES THE DEVICE TO MISINTERPRET AND MISLABEL SOME OF THE DIAGNOSTIC EVENTS. THERE WAS NO PROBLEM IN THE ACTUAL THERAPY. 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 VIRTUOSO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. D164AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other