BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 3

    MDR report key: 1962267 · Received January 18, 2011

    Report

    Report Number
    2124215-2011-00798
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 27, 2010
    Report Date
    February 4, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED THE COMPLETE LEAD WAS RETURNED. ELECTROSURGICAL CAUTERY DAMAGE WAS NOTED IN SEVERAL PLACES ON THE LEAD. DRIED BLOOD/BODY FLUID WAS NOTED IN THE LEAD LUMEN. THE LEAD CONDUCTORS TESTED ELECTRICALLY CONTINUOUS. THE REPORTED LEAD DAMAGE WAS NOT CONFIRMED IN ANALYSIS.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE EXPLANTED PRODUCTS HAVE NOT BEEN RETURNED FOR ANALYSIS. IF THE PRODUCTS ARE RETURNED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE DEVICE REPLACEMENT PROCEDURE, THE RIGHT ATRIAL PORT SET SCREWS AND THE RIGHT VENTRICULAR PACE/SENSE PORT SET SCREWS ON THIS DEVICE HEADER WERE STUCK AND COULD NOT BE RETRACTED. A BIDIRECTIONAL TORQUE WRENCH TIP BROKE OFF IN THE RIGHT VENTRICULAR PACE/SENSE HEX SLOT AFTER TRYING FOUR DIFFERENT WRENCHES. MINERAL OIL WAS ATTEMPTED AND A STERNUM CLIPPER WAS USED TO CUT THE DEVICE HEADER IN AN ATTEMPT TO FREE THE TWO LEADS. THE LEADS REMAINED STUCK IN THE DEVICE HEADER. SUBSEQUENTLY ALL OF THE LEADS WERE CUT AND ABANDONED TO REMOVE THE DEVICE. THE PATIENT WAS THEN TRANSFERRED TO ANOTHER HOSPITAL IN A STABLE CONDITION. ONE DAY LATER, THE LEADS WERE EXTRACTED AND A NEW SYSTEM WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DUE TO THE EXPLANT AND REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4549

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)