BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3904583 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10631
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 17, 2014
    Report Date
    February 16, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LEFT VENTRICULAR (LV) LEAD HAD DISLODGED AND THE PATIENT WAS EXPERIENCING MUSCLE STIMULATION. SUBSEQUENTLY, THE DEVICE WAS PROGRAMMED TO PACE IN THE RIGHT VENTRICLE ONLY AND LV OUTPUTS WERE PROGRAMMED SUB THRESHOLD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE LV LEAD DISLODGMENT THAT HAD PREVIOUSLY BEEN REPORTED OCCURRED AFTER A MITRAL VALVE REPLACEMENT PROCEDURE. SINCE PROGRAMMING THE LV LEAD OFF, THE PATIENT HAS EXPERIENCED AN INCREASE IN HEART FAILURE SYMPTOMS. SUBSEQUENTLY THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LV LEAD WAS SURGICALLY ABANDONED AND THE DEVICE WAS ELECTIVELY EXPLANTED. THE ELECTROPHYSIOLOGIST DOCUMENTED THAT THERE WAS A CLEAR LV LEAD DISLODGEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383567 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R 4470| 4471| 4543| 4473| N119| H177| 4968| 1297