BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIRTUOSO

    MDR report key: 2021066 · Received March 16, 2011

    Report

    Report Number
    2647346-2011-00291
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    December 17, 2006
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE LEAD MODEL 6931 IS PART OF THE ADVISORY.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED BY A FAMILY MEMBER THAT THE PATIENT WAS "SHOCKED TO DEATH BY THE DEFIBRILLATOR".

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT "EXPERIENCED FRIGHTENING EPISODES OF UNNECESSARY SHOCKS AND HAS REQUIRED ADDITIONAL MEDICAL CARE ALONG WITH THE ASSOCIATED COSTS AS A RESULT OF THE DEFECTIVE" LEAD. "AFTER TREMENDOUS SUFFERING", THE PATIENT "ULTIMATELY DIED AS A RESULT OF THE DEFECTIVE" LEAD. APPROXIMATELY THREE YEARS LATER, AN ALLEGATION FROM A SECOND ATTORNEY INDICATED THE PATIENT IMPLANTED WITH A RIGHT VENTRICULAR LEAD IS DECEASED AND NO FURTHER INFORMATION WAS PROVIDED. FURTHER ASSESSMENT OF THE MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED APPROXIMATELY TWO MONTHS POST IMPLANT THE IMPLANTABLE CARDIOVERSION DEFIBRILLATOR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL, INC. D154AWG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| H| L| R