BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 4221016 · Received November 3, 2014

    Report

    Report Number
    2124215-2014-17465
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE PATIENT WAS DIAGNOSED WITH ENDOCARDITIS AND HAD VEGETATION IN THE RIGHT ATRIUM. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702237 ACUITY IMPLANTABLE HF LEAD LWP CPI - DEL CARIBE 4591

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R 4591| N119| 0185| 4136