BEUDAMED
    FDA Adverse Event Death Summary report: N

    MARQUIS

    MDR report key: 2989366 · Received March 5, 2013

    Report

    Report Number
    9614453-2013-00550
    Event Type
    Death
    Date Received
    March 5, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 5, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED AND DIED APPROXIMATELY ONE MONTH POST IMPLANT. THE PATIENT IS REPORTED TO HAVE FELT UNCOMFORTABLE, CALLED FAMILY AND THEN LOST CONSCIOUSNESS AT HOME. THE PATIENT WAS TAKEN TO THE HOSPITAL FOR RESUSCITATION. INFORMATION FROM THE PATIENT'S FAMILY REPORTED THAT THE PATIENT WAS HAVING A TACHYARRHYTHMIA SURROUNDING THE TIME OF DEATH WHICH WAS NOT NOTED DURING DEVICE INTERROGATION. THE PATIENT'S FAMILY REPORTED CONCERN THAT THE DEVICE DID NOT ACCURATELY IDENTIFY THE TACHYARRHYTHMIA. THE PHYSICIAN STATED THE DEATH WAS MORE RELATED TO THE PATIENT'S OWN DISEASE STATUS. AN AUTOPSY WAS PERFORMED AND THE RESULT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94596 MARQUIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND 7230CX

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Death| H| R 6947 IMPLANTABLE TACHY LEAD