BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIRTUOSO DR

    MDR report key: 1050059 · Received May 20, 2008

    Report

    Report Number
    2647346-2008-00269
    Event Type
    Death
    Date Received
    May 20, 2008
    Date of Event
    February 1, 2007
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER : A LAWSUIT ALLEGED THAT THE PATIENT WAS NOT WARNED OF THE "DANGERS ASSOCIATED WITH [HIS] DEFECTIVE" ICD/CRT. THE LAWSUIT FURTHER ALLEGED THAT THE PATIENT SUSTAINED "GREAT PAIN, AGONY, INJURY, SUFFERING, DISABILITY, HOSPITALIZATION, AS WELL AS MENTAL ANGUISH AND EMOTIONAL DISTRESS, ALL OF WHICH CAUSED, PRECIPITATED, AND CONTRIBUTED TO, HIS DEATH." IT IS NOT KNOWN IF THE DEVICE WAS EXPLANTED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE PATIENT'S DEATH WAS DEVICE RELATED. NO CONCLUSION CAN BE DRAWN. DEFECTIVE DEVICE.

    Description of Event or Problem · 1

    A LAWSUIT ALLEGED THAT THE PATIENT WAS NOT WARNED OF THE "DANGERS ASSOCIATED WITH [HIS] DEFECTIVE" ICD/CRT. THE LAWSUIT FURTHER ALLEGED THAT THE PATIENT SUSTAINED "GREAT PAIN, AGONY, INJURY, SUFFERING, DISABILITY, HOSPITALIZATION, AS WELL AS MENTAL ANGUISH AND EMOTIONAL DISTRESS, ALL OF WHICH CAUSED, PRECIPITATED, AND CONTRIBUTED TO, HIS DEATH." IT IS NOT KNOWN IF THE DEVICE WAS EXPLANTED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE PATIENT'S DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154AWG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death| O 4076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD