BEUDAMED
    FDA Adverse Event Death Summary report: N

    MARQUIS VR

    MDR report key: 2223609 · Received August 25, 2011

    Report

    Report Number
    6000094-2011-01823
    Event Type
    Death
    Date Received
    August 25, 2011
    Date of Event
    July 20, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S29
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. FURTHER INFORMATION HAS BEEN REQUESTED, INCLUDING CIRCUMSTANCES SURROUNDING THE DEATH, OTHER IMPLANTED DEVICE, AND A SAVE TO DISK OR DEVICE RETURN. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. FOLLOW UP INFORMATION WAS RECEIVED. THE INTERROGATION FROM AFTER THE DEATH WAS SENT. THE DEVICE APPEARS TO BE SENSING APPROPRIATELY. TWO EPISODES OF VENTRICULAR TACHYCARDIA WERE NOTED, BOTH WERE TREATED APPROPRIATELY AND SUCCESSFULLY WITH ANTI TACHY PACING. THE EXACT EPISODES MENTIONED BY THE PHYSICIAN AND THE EXTERNAL DEFIBRILLATION WERE NOT CAPTURED ON THE INTERROGATION PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AND NO SAVE TO DISK WAS DONE WHICH WOULD BE ABLE TO PROVIDE MORE COMPLETE INFORMATION. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED VENTRICULAR FIBRILLATION AND THE DEVICE FAILED TO DELIVER THERAPY. EXTERNAL DEFIBRILLATION FAILED. THE PATIENT EXPIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED ABOUT BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUIS VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. 7230CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| O| R