BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2920930 · Received January 17, 2013

    Report

    Report Number
    2124215-2013-01164
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 A CHANGE OUT WAS COMPLETED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD BEEN PROGRAMMED TO RIGHT VENTRICLE ONLY. THE REASON FOR THIS RV PROGRAMMING WAS NOT KNOWN. HOWEVER IT HAD BEEN HEARD THAT THE LEFT VENTRICULAR (LV) LEAD WAS NOT WORKING AND HAD DISLODGED. THE MOST RECENT LV LEAD MEASUREMENT WAS FROM 2009. IT WAS SUSPECTED THAT THE LV LEAD HAD EXHIBITED HIGH THRESHOLDS AT THAT TIME. AT THE CHANGE OUT, THIS LV LEAD WAS SURGICALLY ABANDONED, ANOTHER LV WAS NOT IMPLANTED AND THE PATIENT RECEIVED AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INSTEAD OF A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25855 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR H170| 4470| E143| 4543| 0185