BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2060280 · Received April 15, 2011

    Report

    Report Number
    2649622-2011-07187
    Event Type
    Death
    Date Received
    April 15, 2011
    Date of Event
    October 17, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) DISTAL CONDUCTOR FRACTURED AND DISTORTED AND BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER TUBING OVERLAY COSMETIC ESC AND BREACHED CUT, OUTER INSULATION BREACHED CUT, EXPOSED DEFIB COIL WHITE SUBSTANCE, OUTER INSULATION COSMETIC DEPRESSION, BLOOD IN/ON HELIX/LOBE MECHANISM. FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. IT HAD BEEN REPORTED THE PATIENT DIED SUDDENLY APPROXIMATELY FOUR YEARS AFTER IMPLANT AND THE DEATH WAS NOT DEVICE RELATED. HAD ONE VENTRICULAR FIBRILLATION EPISODE THAT WAS APPROPRIATELY TERMINATED. FURTHER REPORTED "DEVICE DATA SHOWS NORMAL FUNCTION." FOLLOW UP REVEALED CAUSE OF DEATH WAS CORONARY ARTERY ATHEROSCLEROSIS. CONDITIONS CONTRIBUTING TO DEATH WERE DIABETES AND HYPERTENSION. MANNER OF DEATH WAS NATURAL. REPORTED THE DEVICE FUNCTIONED AS IT SHOULD AND THE DOCTOR STATED THE LEADS WERE PROPERLY PLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB