BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 3467124 · Received November 13, 2013

    Report

    Report Number
    2649622-2013-13557
    Event Type
    Death
    Date Received
    November 13, 2013
    Date of Event
    October 10, 2006
    Report Date
    October 21, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME ARE BEING REPORTED OCCURED GREATER THAN TWO YEARS FROM TODAY. NO CONTACTS/EVENTS REGARDING THE 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. CONCOMITANT MEDICAL PRODUCTS: IMPLANTABLE PACING LEAD, PRODUCT ID 419478, IMPLANTED: (B)(6) 2006; IMPLANTABLE CARDIO-VERTER DEFIBRILLATOR, PRODUCT ID 7299, IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    A PATIENT WITH AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS REPORTED AS DECEASED BY A FAMILY MEMBER. IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY AND HAD A RECALLED LEAD. IT WAS ALSO REPORTED THAT THE DEVICE HAD BEEN RAPIDLY FIRING AND THE PATIENT DID NOT HAVE A GOOD LIFE FOR THE TWO MONTHS PRIOR TO THE DEATH. INFORMATION IDENTIFIED IN THE MANUFACTURE¿S DATA BASE INDICATED THE PATIENT DIED APPROXIMATELY TWO MONTHS POST IMPLANT OF THE ICD SYSTEM APPROXIMATELY SEVEN YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587472 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Death