BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1852897 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-17181
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 13, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC CRM'S POST MARKET QUALITY ASSURANCE LABORATORY CANNOT CONFIRM THE OBSERVED CLINICAL OBSERVATION OF DISLODGEMENT. HOWEVER, EVIDENCE AND PAST EXPERIENCE SUGGESTS THAT LEAD DISLODGEMENT CAN BE THE RESULT OF UNIQUE PATIENT PHYSIOLOGY AND /OR IMPLANT TECHNIQUE (WHICH IS OFTEN DICTATED BY PATIENT ANATOMY). LEAD DISLODGEMENT IS A POTENTIAL COMPLICATION OF IMPLANTABLE PACING AND IS DESCRIBED IN DEVICE LABELING. BOSTON SCIENTIFIC CRM WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS TO ENSURE THAT NO LEAD DISPLAYS AN ABNORMAL RATE OF OCCURRENCE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD HAD DISLODGED AS A RESULT OF DIAPHRAGM STIMULATION. THEREFORE, A LEAD REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS EXPLANTED. NO 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 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 4542| 4591