BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVERA MRI SR

    MDR report key: 4210923 · Received October 29, 2014

    Report

    Report Number
    9614453-2014-02573
    Event Type
    Death
    Date Received
    October 29, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 7, 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 SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED ADVERSE EVENT. 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 THAT THE PATIENT WAS ENROLLED IN THE (B)(6) STUDY AND THE PATIENT'S FAMILY MEMBER REPORTED TO THE STUDY MANAGER THAT THE PATIENT DIED APPROXIMATELY 4 MONTHS POST IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH DECOMPENSATED HEART FAILURE AND VOLUME OVERLOAD. THE PATIENT WENT INTO CARDIAC ARREST, CPR WAS PERFORMED AND THE PATIENT WAS INTUBATED. A PULSE WAS SENSED BUT THE PATIENT SUBSEQUENTLY DIED. CAUSE OF DEATH WAS CARDIAC ARREST. AN AUTOPSY WAS NOT PERFORMED AND SAVE TO DISK WAS NOT PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693514 EVERA MRI SR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND DVMC3D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Death 6935M62 LEAD