BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 3

    MDR report key: 3052675 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04626
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    August 14, 2010
    Report Date
    February 27, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    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 TWO AND A HALF YEARS AGO THIS LEFT VENTRICULAR (LV) LEAD WAS EXHIBITING AN INCREASE IN THRESHOLD MEASUREMENTS. THE DEVICE WAS PROGRAMMED WITH HIGHER OUTPUTS. NOW, DURING A GENERATOR REPLACEMENT PROCEDURE TO DOWNGRADE THE PATIENT FROM A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TO A DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE LV LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO INTERMITTENT CAPTURE AT 7.0 V/1.7 MS FROM INCREASED THRESHOLDS. IT WAS SUGGESTED THAT THE LEAD HAD PULLED BACK. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156972 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4548

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 4548| 4087| 0158| H177| N119