BEUDAMED
    FDA Adverse Event Death Summary report: N

    EGIDA CRT-D

    MDR report key: 4743247 · Received May 1, 2015

    Report

    Report Number
    9614453-2015-01030
    Event Type
    Death
    Date Received
    May 1, 2015
    Date of Event
    October 17, 2014
    Report Date
    April 17, 2015
    Manufacturer
    MEDTRONIC S.A. (SMO)
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PATIENT DEATH. FOLLOW-UP WAS ATTEMPTED, BUT NO INFORMATION ABOUT THE CIRCUMSTANCES OF THE DEATH COULD BE OBTAINED. THE PATIENT WAS A PARTICIPANT IN THE IMPROVE SUDDEN CARDIAC ARREST (SCA) STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287661 EGIDA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC S.A. (SMO) D394TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Death 6935 LEAD, 4296 LEAD, 4574 LEAD