BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO

    MDR report key: 3993928 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14565
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. CONCOMITANT MEDICAL PRODUCTS: 6944-58 LEAD, IMPLANTED: (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN PERFORMING WIRELESS TELEMETRY A POP UP APPEARED AS "NOISE." THE ELECTROGRAMS AND MARKERS WERE INTERMITTENT. THE ELECTROGRAMS WERE NOTED TO WORK FINE WITH A WANDED PROGRAMMER. THE DEVICE 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
    470331 VIRTUOSO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154AWG

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR 4574-45 LEAD