BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO

    MDR report key: 3990825 · Received August 8, 2014

    Report

    Report Number
    2647346-2014-00061
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THE DEVICE DID NOT EMIT TONES WHEN DEMONSTRATING THE TONES FOR THE PATIENT TO KNOW WHAT THEY COULD HEAR. WHEN THE CLINICIAN PLACED THEIR HEAD NEAR THE IMPLANT SITE, THE CLINICIAN WAS ABLE TO HEAR A FAINT TONE. 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
    468849 VIRTUOSO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO D154VWC

    Patients

    Seq Age Sex Outcome Treatment
    1 00033 YR 694758 LEAD