BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 3994294 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-10123
    Event Type
    Death
    Date Received
    August 8, 2014
    Date of Event
    June 23, 2014
    Report Date
    August 13, 2014
    Manufacturer
    MPRI
    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
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 5076-52, IMPLANTED: (B)(6) 2006, (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY # PRODUCT ID# 693165 A PROXIMAL PORTION WAS RECEIVED MEASURING 4 CM. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WITH AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS DECEASED. THE FAMILY QUESTIONED IF THE DEVICE HAD FAILED. THE CAUSE OF DEATH WAS REPORTED BY THE MEDICAL EXAMINER AS HYPERTENSIVE CARDIOVASCULAR DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472200 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693165

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Death D154AWG ICD