BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK

    MDR report key: 3041179 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-03444
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 25, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT PROGRAMMING CONFIGURATION CHANGES WERE PERFORMED TO RESOLVE THE ISSUE UNTIL THE DEVICE IS CHANGED OUT FOR NORMAL BATTERY DEPLETION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LEFT VENTRICULAR (LV) LEAD DISPLAYED OUT OF RANGE PACING IMPEDANCE GREATER THAN 2000 OHMS AND A LOSS OF CAPTURE (LOC). THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE LOCAL FIELD REPRESENTATIVE WAS ATTEMPTING TO TURN OFF THE LEFT VENTRICULAR (LV) LEAD AT THE TIME. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THE LEFT VENTRICULAR (LV) LEAD DISLODGED. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED FOR NORMAL BATTERY DEPLETION AND THE LV LEAD WAS SURGICALLY ABANDONED AS THE REPLACEMENT DEVICE WAS AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143481 EASYTRAK IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4538

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening| R 4538| 4473| 1280| N119| H170| 4459