BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2993554 · Received March 7, 2013

    Report

    Report Number
    2649622-2013-02510
    Event Type
    Death
    Date Received
    March 7, 2013
    Date of Event
    February 28, 2012
    Report Date
    May 26, 2020
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    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. ADDITIONAL INFORMATION WAS OBTAINED FROM THE PHYSICIAN'S OFFICE, AND PER THE HOSPITAL NOTE THE PATIENT WAS ADMITTED TO HOSPITAL FOR SEPTIC SHOCK DUE TO STREPTOCOCCUS (THE STRAIN WAS NOT PROVIDED). ALSO, VEGETATION WAS NOTED ON THE DEFIBRILLATION LEAD. THE PATIENT'S COURSE PROGRESSED TO RENAL INSUFFICIENCY, HEMODYNAMIC INSTABILITY AND DEATH. THE SOURCE OF THE SEPSIS AND THE CAUSE OF DEATH WERE REQUESTED AND NOT RECEIVED. FOLLOW-UP IS IN PROGRESS. THE DECISION TO REPORT WAS DETERMINED BASED ON INFORMATION THAT WAS AVAILABLE AT THE TIME OF DECISION. SHOULD ADDITIONAL INFORMATION BECOME KNOWN THROUGH FOLLOW-UP, IT WILL BE ADDED TO THE EVENT AND PROCESSED ACCORDINGLY. THE PRODUCT WAS RECEIVED BUT WILL NOT BE ANALYZED DUE TO A LEGAL HOLD. D154ATG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), (B)(6) 2006.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED AND DIED APPROXIMATELY FIVE AND ONE-HALF YEARS POST THE IMPLANT OF THE PATIENT'S DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96863 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Death 5076-45 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD