BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 3102722 · Received May 9, 2013

    Report

    Report Number
    2649622-2013-05389
    Event Type
    Death
    Date Received
    May 9, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 20, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    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. 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. PRODUCT ID: 7232CX, SERIAL# (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF THE LEAD, THE PHYSICIAN HAD TO REPOSITION MANY TIMES TO FIND APPROPRIATE SENSING NUMBERS. THE EVENING AFTER THE IMPLANT, THE PATIENT EXPIRED TO CARDIAC TAMPONADE DUE TO A MYCARDIAL PERFORATION. ADDITIONAL INFORMATION ABOUT THE PATIENT'S CARDIAC DISEASE HAS NOT BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202904 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Death