BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 3061775 · Received April 16, 2013

    Report

    Report Number
    2124215-2013-06278
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    February 8, 2013
    Report Date
    March 18, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    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 THIS LEFT VENTRICULAR (LV) LEAD DISPLAYED HIGH, OUT OF RANGE PACE IMPEDANCE MEASUREMENTS. THE PATIENT WAS SEEN IN CLINIC WHERE THE LV LEAD WAS PROGRAMMED OFF. TWO WEEKS LATER THE PATIENT WAS SEEN FOR FOLLOW UP. AT THAT TIME, THE LEAD WAS ABLE TO BE PROGRAMMED TO A PACING VECTOR THAT DID NOT DISPLAY OUT OF RANGE IMPEDANCES. SUBSEQUENTLY, IT WAS DETECTED VIA THE PATIENT'S REMOTE HOME MONITORING SYSTEM THAT THE RECENTLY PROGRAMMED VECTOR WAS DISPLAYING HIGH, OUT OF RANGE IMPEDANCES. THE PATIENT WILL BE SEEN AT A LATER DATE TO, AGAIN, PROGRAM THE LEAD OFF. AN INTERMITTENT LEAD FRACTURE IS SUSPECTED. THE PATIENT HAD COMPLAINTS OF FEELING FATIGUED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163445 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR N119| 4543| 0157| 4135