BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARQUIS VR

    MDR report key: 2791016 · Received October 15, 2012

    Report

    Report Number
    2647346-2012-01720
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 24, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S29
    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. HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS OF THE DATA REVEALED THAT THERE WAS HIGH RESISTANCE/IMPEDANCE AS THERE WAS ONE PATIENT ALERT FOR RV (RIGHT VENTRICULAR) PACE LEAD Z EQUAL TO 1048 OHMS ON (B)(6) 2009 03:00:05. ALSO, THE WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOW VARIOUS SPIKE INCREASES FOR MAX VENTRICULAR PACE EQUALING 1008 TO 1128 OHMS RANGE BETWEEN (B)(6) 2011 AND (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SENT A REMOTE TRANSMISSION BECAUSE THEY HEARD A BEEPING SOUND FROM THEIR DEVICE. THE LEAD IMPEDANCE TREND DATA WAS BLANK ON THE REMOTE TRANSMISSION. IT WAS NOTED THAT THE PATIENT WAS NEAR A MAGNETIC TOY AT THE TIME. THE DEVICE REMAINS IN USE. ALSO, PERFORMANCE DATA REGARDING THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. 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 55 YR Other