BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIRTUOSO II DR

    MDR report key: 4000627 · Received August 11, 2014

    Report

    Report Number
    3004209178-2014-15140
    Event Type
    Death
    Date Received
    August 11, 2014
    Date of Event
    January 30, 2013
    Report Date
    July 16, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RECEIVED AFTER PATIENT DEATH WITH NO TELEMETRY AND LEADS STILL ATTACHED. AS A RESULT THERE IS NO IMPLANT DATA TO BE RETRIEVED FROM THE DEVICE AND NO IMPLANT DATA WAS PROVIDED FROM THE FIELD. QUERIES TO CARELINK ALSO PROVIDED NO DEVICE DATA. WITHOUT THIS INFORMATION A CONCLUSIVE ANALYSIS CANNOT BE PERFORMED.(B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FROM A MORTUARY WITH NO ADDITIONAL INFORMATION. THE DEVICE WAS ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474959 VIRTUOSO II DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D274DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Death 6947-65 LEAD, 5076-52 LEAD