BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARQUIS VR

    MDR report key: 2812859 · Received October 31, 2012

    Report

    Report Number
    2647346-2012-01775
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 26, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S29
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. POWER ON RESET PARAMETERS WERE NOTED. THERE WERE TWO PORS FOR WRITE TO LOCKED RAM ON (B)(6) 2012. THERE WAS ONE PATIENT ALERT FOR POR ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXPERIENCED TWO ELECTRICAL RESETS DURING THE TIME THAT THE PATIENT WAS RECEIVING RADIATION THERAPY TREATMENTS. THE DEVICE HAD ALSO REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS NOTED THAT THE POWER ON RESET (POR) WAS DUE TO MEMORY DATA CORRUPTION WHICH CLINICIAN FELT IS RELATED TO HIGH ENERGY RADIATION THERAPY THAT THE PATIENT RECEIVED. THE RESETS WERE CLEARED AND 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
    1 MARQUIS VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7230CX

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention 6947 IMPLANTABLE TACHY LEAD