BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 2944594 · Received February 5, 2013

    Report

    Report Number
    2124215-2013-02369
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    May 16, 2012
    Report Date
    May 16, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    G050163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THIS PRODUCT IS NO LONGER IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47524 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R N119| 0184| 4592| 4135