BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 1871873 · Received October 16, 2010

    Report

    Report Number
    2124215-2010-17517
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 21, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE LEAD HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, IT WAS NOTED THAT THE COMPLETE LEAD WAS RETURNED WITH DRIED BLOOD AND BODY FLUID NOTED IN THE LUMEN. THE LEAD WAS SUBJECT TO DIRECT CURRENT RESISTANCE TESTING AND PASSED ON ALL PATHS, VERIFYING THE LEAD'S ELECTRICAL PERFORMANCE WAS INTACT. NO FURTHER TESTING WAS PERFORMED ANALYSIS COULD NOT CONFIRM THE CLINICAL ALLEGATIONS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 1

    THIS LEAD HAS BEEN RETURNED AND IS CURRENTLY UNDERGOING ANALYSIS. THE EVENT WILL BE UPDATED ONCE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO DISLODGEMENT. A NEW NON-BOSTON SCIENTIFIC MANUFACTURED LV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    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 71 YR Hospitalization| L| R N119| 0185| 4554| 4470