BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSO VR

    MDR report key: 1922855 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-06001
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEFIBRILLATOR DEVICE WAS OVERSENSING DUE TO PACING DELIVERED BY A STILL-IMPLANTED PACEMAKER DEVICE, EVEN WITH THE PACEMAKER DEVICE SET TO ITS LOWEST OUTPUT. THE PACEMAKER DEVICE HAS ALREADY REACHED ITS ELECTIVE REPLACEMENT INDICATOR (ERI), AND IS CURRENTLY OPERATING IN VVI PACING MODE AT 65 BEATS PER MINUTE, DESPITE THE PATIENT REPORTEDLY BEING TOLD THAT IT HAD BEEN "TURNED OFF". THE DEFIBRILLATOR DEVICE REMAINS IN USE, AND THE PACEMAKER REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154VWC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention 6947 IMPLANTABLE TACHY LEAD