BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO DR

    MDR report key: 1862949 · Received October 9, 2010

    Report

    Report Number
    6000094-2010-01932
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    July 27, 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 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 SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM SAYING HE RECEIVED SHOCKS FROM THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD). THE DEVICE WAS INTERROGATED AND SHOWED TWO EPISODES OF VENTRICULAR TACHYCARDIA (VT) THAT BROKE WITH ONE BURST OF ANTI-TACHYCARDIA PACING (ATP) AND ONE EPISODE OF VENTRICULAR TACHYCARDIA (VT) THAT FELL INTO THE FAST VENTRICULAR TACHYCARDIA (FVT) ZONE. THE VENTRICULAR TACHYCARDIA (VT) WAS CONVERTED TO SINUS BUT WAS STILL FAST ENOUGH AND CONTINUES TO BE TREATED WITH SIX MORE BURSTS OF (ANTI-TACHYCARDIA PACING) ATP AND ONE SHOCK. THE PATIENT IS TO RECEIVE MORE MEDICATION TO HELP CONTROL HIS HEART RATE, 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 VIRTUOSO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. D164AWG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention