BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3210969 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09479
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 24, 2013
    Report Date
    August 2, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAD WAS EXPLANTED. UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. X-RAY EXAMINATION OF THE LEAD REVEALED THAT A GUIDE WIRE OF FINISHING WIRE WAS LEFT INSIDE OF THE LEAD. SEVERAL BENS WERE OBSERVED ON THE WIRE AND SOME OF THE BENDS SHOWED CONDUCTOR COILS WERE FRACTURED. THE REPORTED CLINICAL OBSERVED WERE CONFIRMED THROUGH LABORATORY ANALYSIS.

    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 DURING A ROUTINE IN-CLINIC FOLLOW UP, THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE (LOC) AND HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,500 OHMS. ADDITIONALLY, THE PATIENT EXPERIENCED SHORTNESS OF BREATH (SOB). IT WAS REPORTED THAT THE PATIENT HAD BEEN LOST TO FOLLOW UP FOR TWO YEARS. A LEAD FRACTURE WAS SUSPECTED, HOWEVER, WAS UNABLE TO BE CONFIRMED THROUGH X-RAY IMAGING. AN INVASIVE PROCEDURE WAS PERFORMED. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309688 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| R 294-03| ZY48JUSBV| 4542| H120| 1298| 430-07