BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2173648 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11055
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 12, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LV LEAD REMAINS IN SERVICE, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    RECEIVED ADDITIONAL INFORMATION THAT THIS LV LEAD WAS SURGICALLY ABANDONED. THERE IS NO INTENDED RETURN OF THIS PRODUCT. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT, WHO HAS THIS LEFT VENTRICULAR (LV) LEAD, DEVELOPED A FEVER, (B)(6). ANTIBIOTICS WERE GIVEN TO THE PATIENT TO TREAT THE (B)(6) INFECTION. THIS WAS SUSPECTED TO BE DUE TO PATIENT CONDITION, AND NOT RELATED TO DEVICE MALFUNCTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4591

    Patients

    Seq Age Sex Outcome Treatment
    1