BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1950632 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-24254
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD WAS PERFORMED. INSPECTION OF THE LEAD BODY AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE RESULTED IN THE CLINICAL OBSERVATION OF DISLODGEMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATTION THAT THIS TRANSVENOUS LEFT VENTRICULAR (LV) LEAD HAD BECOME DISLODGED AND WAS REMOVED FROM SERVICE. THERE WERE NO REPORTED ADVERSE PATIENT SYMPTOMS BEYOND THE NECESSITY OF SURGICAL INTERVENTION.

    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 84 YR 4470| 4543| H220| 4549| 0185