BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO DR

    MDR report key: 2131351 · Received June 16, 2011

    Report

    Report Number
    6000094-2011-01157
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    October 23, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    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 THE PATIENT WAS TRANSFERRED TO THE HOSPITAL FOR INAPPROPRIATE SHOCKS DUE TO RAPID ATRIAL FIBRILLATION. SIXTEEN SHOCKS AND MULTIPLE EPISODES OF ANTI-TACHY PACING WERE SEEN. THE VENTRICULAR TACHYCARDIA ZONE WAS PROGRAMMED OFF AND THE VENTRICULAR TACHYCARDIA ZONE WAS KEPT TO ACTIVATE AT RATES ABOUT TWO HUNDRED BEATS PER MINUTE. IN ADDITION THE PATIENT WAS STARTED ON MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. D164AWG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R