BEUDAMED
    FDA Adverse Event Death Summary report: N

    EASYTRAK 3

    MDR report key: 4132914 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-17737
    Event Type
    Death
    Date Received
    October 1, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) ON (B)(6) 2014. THE LOCAL REPRESENTATIVE WAS CONTACTED BY THE PATIENT'S DEVICE-FOLLOWING CLINIC AND WAS INFORMED THAT THIS PATIENT HAD DIED ON (B)(6) 2014 DURING A REVISION PROCEDURE. THE LOCAL REPRESENTATIVE COMMENTED THAT THE PATIENT HAD DEVELOPED A POCKET INFECTION/EROSION. TS WAS INFORMED THAT THE PHYSICIAN HAD PLANNED TO IMPLANT A DEVICE ON THE OPPOSITE SIDE. THE LOCAL REPRESENTATIVE WAS NOT AWARE OF THE SPECIFIC DETAILS AS THE REPORTED INFECTION/EROSION, REVISION PROCEDURE AND PATIENT DEATH OCCURRED OUTSIDE OF THIS LOCAL REPRESENTATIVE'S TERRITORY. BOSTON SCIENTIFIC RECEIVED INFORMATION FROM ANOTHER LOCAL REPRESENTATIVE. THIS REPRESENTATIVE HAD BEEN PAGED ON (B)(6) 2014 TO PERFORM A DEVICE CHECK AT A LOCAL HOSPITAL. THE PHYSICIAN WANTED THE DEVICE INTERROGATED TO DETERMINE WHETHER THIS PATIENT WAS PACEMAKER DEPENDENT. THE DEVICE WAS INTERROGATED AND A REVIEW OF THE ELECTROGRAM FOUND THAT THE PATIENT WAS IN COMPLETE HEART BLOCK. THE PHYSICIAN WAS CONTACTED BY PHONE WITH THIS OBSERVATION AND WAS TOLD THAT THE DEVICE WAS EXHIBITING NORMAL FUNCTION. ADDITIONALLY, THE LOCAL REPRESENTATIVE WAS INFORMED ON THIS DATE THAT THE PATIENT HAD DEVELOPED AN INFECTION/EROSION. VISUAL INSPECTION OF THE POCKET SITE FOUND THAT THE DEVICE HAD STARTED TO MIGRATE AND A PORTION OF THE LEADS HAD ERODED THROUGH THE SKIN. THIS REPRESENTATIVE HAD NO FURTHER CONTACT WITH THIS PATIENT AND WAS NOT PRESENT DURING THE REVISION PROCEDURE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613278 EASYTRAK 3 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4525

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| H| L| R H215| MISMATCH| 0175| 4470| 4525| N164