BEUDAMED
    FDA Adverse Event Death Summary report: N

    EASYTRAK 2 IS-1

    MDR report key: 5573556 · Received April 13, 2016

    Report

    Report Number
    2124215-2015-00206
    Event Type
    Death
    Date Received
    April 13, 2016
    Date of Event
    November 24, 2014
    Report Date
    August 18, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    UDI-DI
    00802526410994
    PMA / PMN Number
    P010012/S024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ORIGINALLY SUBMITTED VIA ASR ON REPORT ID #(B)(4) IN Q1/2015 OF THE ASR REPORT SUBMITTED TO THE FDA ON #E2011006, WHICH WAS REVOKED ON 10/02/2017. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    MANUFACTURER REPORT ID #2124215-2015-00206 CORRESPONDS TO THE INITIAL ASR REPORT SUBMITTED FOR EXEMPTION #E2011006. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED. BOSTON SCIENTIFIC RECEIVED A PATIENT VERIFICATION FORM IN MARCH OF 2016 THAT WAS RETURNED WITH A HANDWRITTEN NOTE FROM THE PATIENT'S SPOUSE. THE NOTE STATED THE PATIENT DIED ON (B)(6) 2014 DUE TO AN INFECTED PACEMAKER LEAD. BOSTON SCIENTIFIC WAS NOT PREVIOUSLY AWARE THAT THE PATIENT DIED AS A RESULT OF THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231001 EASYTRAK 2 IS-1 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D NIK BOSTON SCIENTIFIC CORPORATION 4543 00802526410994

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Life Threatening| H| R| D