BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO VR

    MDR report key: 1013494 · Received March 10, 2008

    Report

    Report Number
    2647346-2008-00093
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    September 7, 2007
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: ANALYSIS CONFIRMED THE REPORTED HIGH LEAD IMPEDANCES AND SENSING DIFFICULTIES AS WELL AS LOSS OF OUTPUT WITHOUT A MAGNET PRESENT. IT WAS DETERMINED THAT THIS WAS CAUSED BY A LEAKY CAPACITOR THAT SUPPORTS A SEGMENT OF THE PACING OUTPUT CIRCUITRY. DURING FURTHER TESTING THE DEVICE INADVERTENTLY CHARGED TO HIGH VOLTAGE AND ARCING OCCURRED ON THE HYBRID RESULTING IN IRREVERSIBLE DAMAGE INTERNAL TO THE DEVICE. AS A RESULT, FURTHER TESTING COULD NOT BE PERFORMED.

    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 MED REL, INC. D154VWC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Other