BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIRTUOSO II DR

    MDR report key: 3230021 · Received July 16, 2013

    Report

    Report Number
    3004209178-2013-11857
    Event Type
    Death
    Date Received
    July 16, 2013
    Date of Event
    May 15, 2013
    Report Date
    February 28, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-0117-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 694758 IMPLANTABLE TACHY LEAD, IMPLANTED: (B)(6) 2004; 4568-45 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2004. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE RETURNED DEVICE INDICATED A FIRMWARE ERROR MESSAGE/CODE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED. THE PATIENT'S FAMILY/FRIEND RETURNED THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ( ICD) SYSTEM AFTER EXPLANT BY THE MORTUARY TO THE PHYSICIAN'S OFFICE. IT WAS FURTHER REPORTED THAT WHEN ATTEMPTING TO INTERROGATE THE DEVICE, A POWER ON RESET (POR) MESSAGE WAS OBSERVED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328711 VIRTUOSO II DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D274DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Death