BEUDAMED
    FDA Adverse Event Death Summary report: N

    FINELINE II

    MDR report key: 1674432 · Received May 4, 2010

    Report

    Report Number
    2124215-2010-09413
    Event Type
    Death
    Date Received
    May 4, 2010
    Date of Event
    April 8, 2010
    Report Date
    April 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT HAS NOT BEEN RETURNED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFO BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THIS PT WAS ADMITTED TO THE HOSP POST DEVICE REPLACEMENT PROCEDURE WITH PNEUMONIA. IT WAS REPORTED THAT THE PT EXPIRED IN THE HOSP NINE DAYS POST REPLACEMENT PROCEDURE, DUE TO SEPSIS AND CARDIOPULMONARY ARREST. THE PHYSICIAN REPORTED THAT THE CAUSE OF DEATH WAS NOT DEVICE RELATED, AND THERE WAS NO INFECTION NOTED AT THE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death 4456| S606| 4469| 1290