BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO DR

    MDR report key: 1864686 · Received October 12, 2010

    Report

    Report Number
    6000144-2010-05138
    Event Type
    Malfunction
    Date Received
    October 12, 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 THERE WAS NOISE SEEN ON THE ELECTROGRAM AND THAT IS WAS REPRODUCIBLE WITH ISOMETRICS. THE SHORT INTERVAL COUNT WAS ALSO HIGH. THE DEVICE IS STILL 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
    1 VIRTUOSO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154AWG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other 6947 IMPLANTABLE TACHY LEAD| 5594 IMPLANTABLE PACING LEAD