BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIRTUOSO DR

    MDR report key: 3133130 · Received May 29, 2013

    Report

    Report Number
    9614453-2013-01064
    Event Type
    Death
    Date Received
    May 29, 2013
    Date of Event
    April 13, 2013
    Report Date
    April 16, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. MODEL NUMBER D164AWG IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS IN THE SAME BRAND FAMILY AS A DEVICE MARKETED IN THE U.S. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. HOWEVER, IF ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AND WILL NOT BE EVALUATED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) WAS DECEASED. THE PATIENT DIED APPROXIMATELY FOUR YEARS POST IMPLANT OF THE ICD. THE CAUSE OF DEATH IS UNKNOWN AND IT WAS REPORTED, IT IS UNKNOWN IF THE DEVICE CAUSED THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236090 VIRTUOSO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D164AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Death