BEUDAMED
    FDA Adverse Event Death Summary report: N

    FINELINE II

    MDR report key: 6177329 · Received December 15, 2016

    Report

    Report Number
    2124215-2016-21052
    Event Type
    Death
    Date Received
    December 15, 2016
    Date of Event
    October 19, 2016
    Report Date
    December 2, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED LEAD WAS NOT RETURNED. 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 ADDITIONAL INFORMATION. IT WAS LATER REPORTED BY THE PATIENT ADVOCATE THAT THE PATIENT HAD REMAINED HOSPITALIZED POST-EXTRACTION. THE PATIENT HAD PASSED AWAY IN THE HOSPITAL EIGHT DAYS AFTER THE PROCEDURE, WHILE WAITING FOR A NEW SYSTEM TO BE IMPLANTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. SURGICAL INTERVENTION WAS PERFORMED AND THE RA LEAD WAS EXTRACTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828348 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| H| L| R 4470| 4471| 5071| 8042| MISMATCH