BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 1864080 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15930
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 8, 2010
    Report Date
    August 9, 2010
    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 WAS EXPLANTED, BUT IT IS UNKNOWN WHETHER IT WILL 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO INFECTION. THERE WERE NO OTHER 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 60 YR 0295| 4591| P108| 4096| 4542