BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2163469 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07655
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    February 22, 2010
    Report Date
    April 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    G050163
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS PRODUCT EXPERIENCED SWELLING AND EXTENSIVE BRUISING OVER THE IMPLANT SITE THREE DAYS AFTER BEING DISCHARGED FOR THE IMPLANT PROCEDURE. THE PATIENT FELT NUMBNESS AND TINGLING TO THE LEFT OF THE FOREARM AREA AND WAS ADMITTED TO THE HOSPITAL EMERGENCY ROOM. THE PATIENT WAS EVALUATED, A POCKET INFECTION WAS NOTED AND INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED. A PROCEDURE WAS PERFORMED TO SUCCESSFULLY EVACUATE HEMATOMA. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THIS PROCEDURE.

    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 81 YR Hospitalization| L| R (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)