BEUDAMED
    FDA Adverse Event Death Summary report: N

    GEM VR

    MDR report key: 2130878 · Received June 16, 2011

    Report

    Report Number
    2647346-2011-00888
    Event Type
    Death
    Date Received
    June 16, 2011
    Date of Event
    September 3, 2003
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P900061/S35
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED INADVERTENTLY WITH THE INCORRECT REPORT TYPE CODE. IN ERROR THE REPORT TYPE CODE 5 DAY WAS INADVERTENTLY SELECTED. THE CORRECT REPORT TYPE CODE SHOULD HAVE BEEN 30 DAY. AND THEREFORE, A SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED TO ACCURATELY REFLECT THIS EVENT AS A 30-DAY REPORTABLE EVENT. THIS DEATH EVENT HAS BEEN REPORTED BY THE PATIENT'S SPOUSE. THE DEATH OCCURRED SEVEN YEARS AGO AND NO CONTACTS/EVENTS REGARDING THE ICD SYSTEM HAVE EVER BEEN RECEIVED/REPORTED. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS DEATH EVENT HAS BEEN REPORTED BY THE PATIENT'S SPOUSE. THE DEATH OCCURRED SEVEN YEARS AGO AND NO CONTACTS/EVENTS REGARDING THE ICD SYSTEM HAVE EVER BEEN RECEIVED/REPORTED. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S FAMILY MEMBER THAT THE PATIENT DIED AFTER RECEIVING A DELAYED SHOCK. IN ADDITION THE FAMILY MEMBER REPORTED THAT THE PATIENT DIED OF A CARDIAC ARREST. THE PATIENT DIED FOUR YEARS AFTER IMPLANT OF THE DEVICE AND LEAD SEVEN YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7227CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death