BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARQUIS

    MDR report key: 3071806 · Received April 22, 2013

    Report

    Report Number
    9614453-2013-01028
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED AND REVEALED THAT THE REPORTED POWER ON RESET (POR) WAS NOT DETERMINED. THE DEVICE ELECTIVE REPLACEMENT INDICATOR WAS CAUSED BY BATTERY DEPLETION DUE TO HIGH CURRENT DRAIN IN THE DEVICE. THE HIGH CURRENT DRAIN WAS ATTRIBUTED TO THE POR WHICH ENABLED THE VOLTAGE DOUBLER GENERATING EXCESS CURRENT. IF A POR OCCURS WHILE IN THE SHIPPING BOX, THE CURRENT DOUBLER BECOMES ACTIVE, CAUSING A HIGH CURRENT DRAIN TO THE DEVICE DUE TO THE FUNCTIONALITY OF THE VOLTAGE DOUBLER.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PROGRAMMING AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STILL IN THE ORIGINAL PACKAGING, IT WAS REVEALED THAT THE ICD HAD EXPERIENCED AN ELECTRICAL RESET AND HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). A NEW DEVICE WAS USED IN ITS PLACE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172559 MARQUIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND 7230CX

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR