BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO VR

    MDR report key: 2243581 · Received September 12, 2011

    Report

    Report Number
    6000094-2011-01833
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    July 26, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    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.

    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 DEVICE 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 WHILE WASHING DISHES, THE PATIENT EXPERIENCED NUMBNESS IN THE HAND AND APPROXIMATELY TWO MINUTES LATER RECEIVED THERAPY. IT WAS FURTHER REPORTED THAT PHYSICIAN REVIEW OF THE EPISODE DETERMINED THERAPY WAS DUE TO ELECTRICAL INTERFERENCE. FURTHER INVESTIGATION BY THE FACILITY REVEALED STRAY VOLTAGE FROM EXTERNAL EQUIPMENT WAS PRESENT AT THE TIME OF THE OCCURRENCE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. D164VWC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening| O