BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 4140018 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16960
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    August 28, 2014
    Report Date
    October 16, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REPLACEMENT PROCEDURE FOR THE LV LEAD IS CURRENTLY BEING PLANNED. THIS REPORT WILL BE UPDATED ONCE THIS EVENT OCCURS AND/OR THE PRODUCT GETS RETURNED FOR ANALYSIS.

    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

    ADDITIONAL INFORMATION PROVIDED FROM THE FIELD INDICATED THAT A REVISION PROCEDURE WAS PERFORMED AND THE PATIENT¿S LV WAS SURGICALLY ABANDONED WHILE THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS PRESENTED TO THEIR FOLLOW-UP CLINIC WITH INCREASING SHORTNESS OF BREATH AT REST AND WITH EXERCISE. UPON INTERROGATION, THE PATIENT¿S LEFT VENTRICULAR (LV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT OF GREATER THAN 2000 OHMS. NO CAPTURE AT MAXIMUM OUTPUTS WAS ALSO OBSERVED. THE PATIENT¿S CRT-D WAS REPROGRAMMED TO VVI 40 AND THE LV LEAD WAS DEACTIVATED. THE PHYSICIAN SUSPECTS THE LV LEAD WAS FRACTURED AND A REPLACEMENT PROCEDURE IS CURRENTLY BEING PLANNED. FOR NOW, THE LV LEAD AND CRT-D REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620695 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4517

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR N165| 0148| H155| A135| 4517| 4471| H195