BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO VR

    MDR report key: 3860856 · Received June 10, 2014

    Report

    Report Number
    6000094-2014-00008
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    November 13, 2013
    Report Date
    March 17, 2014
    Manufacturer
    MEDTRONIC S.A. (SMO)
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO NOISE AND OVERSENSING FROM ELECTROMAGNETIC INTERFERENCE. THE DEVICE AND LEAD REMAIN 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
    343290 VIRTUOSO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC S.A. (SMO) D164VWC

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| L| R 6948 LEAD