BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1863657 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15849
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 27, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS IS CURRENTLY ON-GOING. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    --

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION REVEALED THAT THE COMPLETE LEAD WAS RETURNED AND THE COILS WERE FRACTURED. THERE WERE NO OBVIOUS SIGNS OF A SUTURE SLEEVE MARK/FOOTPRINT OBSERVED, HOWEVER, BY PLACING A SUTURE SLEEVE USES WITH THIS LEAD MODEL SHOWED PUCKER LOCATION WOULD BE AT THE DISTAL END OF THE SUTURE SLEEVE AND THE FRACTURE LOCATION WOULD BE DIRECTLY UNDERNEATH THE SUTURE SLEEVE. LABORATORY ANALYSIS CONCLUDED THAT THE LEAD COILS WERE FRACTURED ON BOTH THE CONDUCTIVE PATHWAYS, THE CLINIC OBSERVATION OF HIGH IMPEDANCES WERE LIKELY A DIRECT RESULT OF THIS OBSERVATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCES ON THE RIGHT ATRIAL (RA) LEAD AND THE LEFT VENTRICULAR (LV) LEAD. IT WAS REPORTED THAT THE PATIENT HAD RECENTLY TAKEN A "MILD" FALL. SUBSEQUENT THE LEADS EXTRACTED AND THE CRT-D WAS EXPLANTED. THE CAUSE OF THE HIGH IMPEDANCE ISSUE WAS UNDETERMINED AT THE TIME OF EXPLANT. NEW LEADS AND CRT-D WERE SUCCESSFULLY PLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THIS PRODUCT WAS NO LONGER FUNCTIONING PRIOR TO EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention 4470| N119| N118| H175| 4549| 4518| 0185