BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 1862181 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-15646
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 28, 2010
    Report Date
    August 24, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT BOSTON SCIENTIFIC CRM, VISUAL INSPECTION NOTED THE COMPLETE LEAD WAS RETURNED. THE SPIRAL FIXATION MECHANISM APPEARED NORMAL. THE LEAD PASSED CONDUCTOR RESISTANCE, HIGH POTENTIAL, AND INSULATION PRESSURE TESTING, CONFIRMING THE CONDUCTOR AND INSULATION WERE UNCOMPROMISED AND INTACT.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD DISLODGED INTO THE RIGHT ATRIUM (RA). A LEAD REVISION WAS PERFORMED WHERE THIS LEAD WAS EXPLANTED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. OTHER THAN THE PROCEDURE, 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 58 YR Life Threatening| R N119| 4543| 4592| 4542| 4470| 0185