BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO DR

    MDR report key: 1875094 · Received October 19, 2010

    Report

    Report Number
    6000144-2010-05441
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    August 16, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S062
    Removal / Correction Number
    Z-0128-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    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

    THE PATIENT REPORTED LAST DEVICE CHECK WAS 2 MONTHS AGO/UNDERSTOOD "SERIOUSLY LOW BATTERY". PATIENT HAD SCHEDULED APPT. FOR FOLLOWUP NEXT MONTH. INDICATED DEVICE WAS BEEPING DAILY UNTIL "ABOUT 2 DAYS AGO" AND IS NOW "FEELING HARD HEART BEATS" IN THE MORNING AND FEELS HE IS NO LONGER BEING PACED. THE DEVICE IS STILL IN USE. 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 DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154AWG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD