BEUDAMED
    FDA Adverse Event Death Summary report: N

    POLYFLEX

    MDR report key: 1652805 · Received April 5, 2010

    Report

    Report Number
    2124215-2010-06794
    Event Type
    Death
    Date Received
    April 5, 2010
    Date of Event
    March 11, 2010
    Report Date
    March 11, 2010
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WILL BE RETAINED BY THE MEDICAL EXAMINER AND WILL NOT BE RETURNED. NO ADD'L INFO IS AVAILABLE AT THIS TIME. IF THE PRODUCT IS RETURNED, OR IF ADD'L INFO BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THIS PT HAD PREVIOUSLY BEEN SEEN AT A DIFFERENT INSTITUTION FOR A PULMONARY EMBOLISM AND UNDERWENT A SEPARATE PROCEDURE PRIOR TO THIS EVENT. UPON DISCHARGE FROM THE PREVIOUS PROCEDURE, THE PT BECAME SEPTIC AND DEVELOPED A SYSTEMIC INFECTION WHICH INVOLVED THE CHRONIC PACING LEADS. THE PT HAD ALSO DEVELOPED VEGETATION IN THE RIGHT ATRIUM (RA). A REVISION PROCEDURE WAS SCHEDULED. DURING THE REVISION PROCEDURE, THE PT WAS PLACED ON THE CARDIOPULMONARY BYPASS MACHINE FOR LASER LEAD EXTRACTION TO REMOVE THE INFECTED PACING SYSTEM AND REMOVE THE VEGETATION FROM THE RA. AFTER THE CHRONIC SYSTEM WAS EXPLANTED, A NEW DEVICE AND TWO EPICARDIAL LEADS WERE IMPLANTED. WHILE ATTEMPTED TO REMOVE THE PT FROM THE CARDIOPULMONARY BYPASS MACHINE, THE PT'S PREVIOUSLY NOTED PULMONARY EMBOLISM BECAME EXACERBATED, AND THE PT EXPIRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLEX IMPLANTABLE LEAD DTB GUIDANT ANGLETON/ST. PAUL 480-01

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death RU48TJSBV| 4046| 476-01| 284-02| 2550| 4047| 253-05| S603| 480-01