BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2052309 · Received April 12, 2011

    Report

    Report Number
    2182208-2011-00633
    Event Type
    Death
    Date Received
    April 12, 2011
    Date of Event
    February 25, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM (B)(6) INDICATED THE PATIENT HAD AN ADDITIONAL LEAD AT THE TIME OF DEATH. THE LEAD 5076 IS BEING SUBMITTED VIA A INDIVIDUAL MDR. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WITH AN IMPLANTABLE CARDIAC DEFIBRILLATOR DIED OF SUDDEN CARDIAC DEATH AND ISCHEMIC HEART DISEASE. THE PATIENT HAD A HISTORY OF ATRIAL FLUTTER AND AN ABLATION PROCEDURE TWENTY THREE DAYS PRIOR TO DEATH. NO RECORDS HAVE BEEN MADE AVAILABLE OTHER THAN A DEATH CERTIFICATE. IT WAS NOTED BY THE CORONER THAT IT WAS A "NATURAL EXPECTED DEATH" AND NO CORONERS REPORT WAS WRITTEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death