BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO II VR

    MDR report key: 3861491 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11198
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    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 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED AT THE EMERGENCY ROOM (ER) AFTER RECEIVING THREE SHOCKS. THE ELECTROGRAM INDICATED THAT THE WAVELETS WERE NOT MATCHING THE DETECTIONS. THERAPY WAS INEFFECTIVE. FOLLOW-UP WITH CLINIC REVEALED THAT NO PROGRAMMING CHANGES HAVE BEEN MADE, AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342102 VIRTUOSO II VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D274VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Hospitalization| L 6947 LEAD