BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1874087 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-19323
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION NOTED A DEFORMATION OF THE CONDUCTOR COILS LOCATED AT 185 AND 238 MM FROM THE TERMINAL PIN. ADDITIONALLY, THE CONDUCTOR COILS WERE CRUSHED 650, 656 MM FROM THE TERMINAL PIN. TESTING DETERMINED THIS DAMAGE HAD BEEN THE RESULT OF THE EXPLANT PROCEDURE. RESISTANCE TESTING WAS PERFORMED WHICH CONFIRMED THE ELECTRICAL CONTINUITY OF THE LEAD. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD WAS EXPLANTED DUE TO AN UNSPECIFIED PRODUCT PERFORMANCE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 64 YR N119| H225| MISMATCH| 0157| 4518| 4135