BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 1875018 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18928
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 4, 2010
    Report Date
    September 5, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    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, VISUAL INSPECTION OF THE LEAD NOTED DRIED BLOOD IN THE LEAD LUMEN. THE LEAD PASSED CONDUCTOR RESISTANCE AND INSULATION PRESSURE TESTING, CONFIRMING BOTH THE CONDUCTOR AND INSULATION WERE UNCOMPROMISED. ANALYSIS WAS UNABLE TO CONFIRM OR REFUTE THE ALLEGATIONS OF DIAPHRAGMATIC STIMULATION AND DISLODGEMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED DIAPHRAGMATIC STIMULATION, LOSS OF CAPTURE, AND WAS SUSPECTED OF HAVING DISLODGED. THE LEAD WAS ELECTRICALLY DEACTIVATED. IN A REVISION PROCEDURE, THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED BY A NEW LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention N119| 4592| 4136| 0184