BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVERA MRI SR

    MDR report key: 4112995 · Received September 24, 2014

    Report

    Report Number
    9614453-2014-02068
    Event Type
    Death
    Date Received
    September 24, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 28, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    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 THE PATIENT, WHO WAS A PARTICIPANT IN THE (B)(6) CLINICAL STUDY, IS DECEASED. THE EXACT DATE OF DEATH IS UNKNOWN; HOWEVER, THE PATIENT IS REPORTED TO HAVE DIED WITHIN APPROXIMATELY TWO MONTHS OF IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. THE PATIENT IS REPORTED TO HAVE DIED AT HOME. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593212 EVERA MRI SR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND DVMC3D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Death 6935M-62 LEAD