BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIRTUOSO VR

    MDR report key: 2954593 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02460
    Event Type
    Death
    Date Received
    February 11, 2013
    Date of Event
    December 20, 2012
    Report Date
    February 19, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CLINIC REPORTED THAT THE PATIENT IS DECEASED. THE PATIENT IS REPORTED TO HAVE DIED AT HOME.THE DATE OF DEATH AND ANY INFORMATION RELATED TO THE DEATH WERE NOT KNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE IMPLANTING PHYSICIAN AND THE PRIMARY PHYSICIAN RELATED TO THE CAUSE OF DEATH WERE UNSUCCESSFUL. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE SHOCKS FOR SUPRAVENTRICULAR TACHYCARDIA (SVT). IT WAS FURTHER REPORTED THAT THE DEVICE HAD HELD THERAPY UNTIL THE RATE HAD EXCEEDED THE SVT LIMIT. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57933 VIRTUOSO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154VWC

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Death| L 6947 IMPLANTABLE DEFIB LEAD