BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARQUIS VR

    MDR report key: 1990263 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00679
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 6, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S29
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE QUESTION MARKS WERE FOUND UNDER THAT BATTERY VOLTAGE AND PACING PERCENTAGES FOLLOWING INTERROGATION. THE DEVICE WAS REINTERROGATED WITH THE SAME DISPLAY. 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 MARQUIS VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7230CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other (B)(4) IMPLANTABLE TACHY LEAD