BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACUITY

    MDR report key: 6029023 · Received October 13, 2016

    Report

    Report Number
    2124215-2016-16914
    Event Type
    Death
    Date Received
    October 13, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 15, 2016
    Manufacturer
    CPI PLANT - ST. PAUL
    Product Code
    LWP
    PMA / PMN Number
    P010012/S398
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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 THE PATIENT WITH THIS SYSTEM PASSED AWAY DUE TO PROGRESSIVE MULTIPLE ORGAN FAILURE, POST A (B)(6) INFECTION. NO RETURN OF PRODUCT IS EXPECTED AND NO ALLEGATIONS INFECTION WAS PROCEDURE OR PRODUCT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678551 ACUITY IMPLANTABLE LEAD LWP CPI PLANT - ST. PAUL 4671

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death 4137| 4470| 4471| 4671| 4677| MISMATCH| U128