BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2153450 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06580
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 28, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT THE COMPLETE LEAD WAS RETURNED WITH DRIED BLOOD IN THE LEAD LUMEN AND A SET SCREW MARK NOTED ON THE TERMINAL PIN AND RING. FURTHER VISUAL INSPECTION SHOWED THAT BOTH TINES REMAINED INTACT AT THE DISTAL TIP OF THE LEAD. THE LEAD WAS SUBJECT TO DIRECT CURRENT RESISTANCE TESTING AND PASSED ON ALL PATHS, VERIFYING THE LEAD'S ELECTRICAL PERFORMANCE WAS INTACT. NO FURTHER TESTING WAS PERFORMED ANALYSIS COULD NOT CONFIRM THE CLINICAL ALLEGATIONS OBSERVED IN THE FIELD.

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT TWO AND A HALF WEEKS POST IMPLANT THE LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO LOSS OF PACING AT MAXIMUM OUTPUTS AND A SUSPECTED LEAD DISLODGEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE LEAD REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R 4058M| 0181| 4087| 4543| N119| KDR901| 5024M| 4195