BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 5850848 · Received August 5, 2016

    Report

    Report Number
    2182208-2016-01816
    Event Type
    Death
    Date Received
    August 5, 2016
    Date of Event
    July 11, 2016
    Report Date
    August 5, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0068-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: D354DRG IMPLANTED: (B)(6) 2012. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED. INFORMATION RECEIVED REPORTED THE PATIENT FAINTED AT HOME, EMERGENCY SERVICES WERE CONTACTED AND THE PATIENT WAS SHOCKED BY AN EXTERNAL DEFIBRILLATOR. HIGH RATE NON-SUSTAINED NOISE WAS RECORDED THE BY THE DEVICE. A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED DUE TO NOISE AND SENSING INTEGRITY COUNTER (SIC). VENTRICULAR UNDERSENSING WAS ALSO REPORTED WITH SMALL R WAVE AMPLITUDE. THE PATIENT WAS DECLARED BRAIN DEAD, ALL CARES WERE STOPPED AND THE PATIENT DIED. THE CAUSE OF DEATH WAS REPORTED AS VENTRICULAR FIBRILLATION (VF).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501203 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6931

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death