BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 1861010 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15341
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 19, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    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 DID NOT ALLOW INSERTION OF A STYLET DUE TO THE DRIED BLOOD. THE LEAD PASSED CONDUCTOR RESISTANCE, HIGH POTENTIAL, AND INSULATION PRESSURE TESTING, CONFIRMING BOTH THE CONDUCTOR AND INSULATION WERE UNCOMPROMISED. ANALYSIS WAS UNABLE TO CONFIRM OR REFUTE THE CAUSE OF THE DISLODGEMENT.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    --

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4554

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R