BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2060121 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05699
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    December 1, 2010
    Report Date
    April 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    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, THE LEAD WAS THOROUGHLY INSPECTED AND ANALYZED THE COMPLETE LEAD WAS RETURNED. POLY/SILICONE TRANSITION WAS SEPARATED COMPLETELY AROUND THE CIRCUMFERENCE OF THE LEAD 840MM FROM THE TERMINAL PIN. THERE WAS A 110MM GAP BETWEEN THE DISTAL EDGE OF THE POLY AND THE PROXIMAL EDGE OF THE SILICONE. THE CONDUCTOR COILS WERE EXTREMELY STRETCHED FROM 630MM TO THE TIP. THE SILICONE INSULATION WAS BUNCHED UP BETWEEN 965 AND 973MM FROM THE TERMINAL PIN. TEAR HOLES WERE OBSERVED IN THE INSULATION IN THIS STRETCHED AREA. A BEND WAS NOTED IN THE CONDUCTOR COILS AND LEAD BODY 65MM FROM THE TIP. THE POLYURETHANE TUBING WAS PUCKERED APPROXIMATELY 426-432 MM FROM THE TERMINAL PIN, WHICH APPEARED TO BE THE SUTURE SLEEVE TIE DOWN SITE. THE CONDUCTOR COILS WERE FRACTURED APPROXIMATELY 435-436MM FROM THE TERMINAL PIN AND THE LEAD POLY APPEARED BENT/CREASED 434MM FROM THE TERMINAL PIN. CORRESPONDING WITH THE RIDGE GROOVES ON THE SUTURE SLEEVE, INDENTATION MARKINGS ON THE POLYURETHANE LEAD MATERIAL WERE ALSO OBSERVED ON THE LEAD; THIS DAMAGE CORRESPONDED WITH THE FRACTURE SITE. NO FURTHER TESTING WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    DUE TO THE SUSTAINED DAMAGE DURING EXPLANT, THE LV LEAD WAS NOT TO BE RETURNED FOR RELIABILITY ANALYSIS. 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT LEFT VENTRICULAR (LV) PACING IMPEDANCE MEASUREMENTS WERE GREATER THAN 2,000 OHMS, WITH INCREASED THRESHOLD MEASUREMENTS AND NOTED LOSS OF CAPTURE. FLUOROSCOPY IMAGES CONFIRMED THAT THE LV LEAD HAD FRACTURED IN THE POCKET AREA, WITH APPROXIMATELY 30 CM OF THE LEAD WOUND TIGHTLY IN THE POCKET. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS EXTRACTED. UPON EXTRACTION, THE LEAD BROKE INTO SEVERAL PIECES, HOWEVER, THE ENTIRE LEAD WAS SUCCESSFULLY REMOVED. A NEW LV LEAD WAS PLACED AND NO OTHER 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 75 YR Hospitalization| R H215| T125| 4512| 0137| 4518| 4469