BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSAR MAX II

    MDR report key: 1210807 · Received October 23, 2008

    Report

    Report Number
    2124215-2008-99962
    Event Type
    Death
    Date Received
    October 23, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 23, 2008
    Product Code
    DXY
    Removal / Correction Number
    Z875/897-3
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. TS ASKED THE CALLER IF SHE KNEW IF THE PATIENT'S DEVICE WAS RETURNED TO BSC. THE CALLER STATED SHE BELIEVES THE DEVICE WAS BURIED WITH HER FATHER. A REQUEST FOR ADDITIONAL INFORMATION WAS EMAILED TO THE BSC SALES REPRESENTATIVE (SR), HOWEVER, EFFORTS TO RECEIVE THIS INFORMATION WAS UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED, THIS EVENT WILL BE UPDATED APPROPRIATELY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) CRM RECEIVED INFORMATION THAT THIS PATIENT'S DAUGHTER CALLED TECHNICAL SERVICES (TS) STATING SHE RECEIVED A LETTER FROM BSC AND NOTED HER FATHER PASSED AWAY A YEAR AGO. TS ASKED IF THE PATIENT'S DEATH WAS RELATED TO HIS PACEMAKER. THE CALLER STATED HER FATHER NEEDED SURGERY, BUT WAS TOLD HE COULDN'T HAVE IT BECAUSE HIS PACEMAKER WAS NOT WORKING PROPERLY. TS NOTED THAT IT SOUNDED LIKE THE PATIENT DEVELOPED DIABETES AND GANGRENE, ACCORDING TO THE CALLER, AND NEEDED HIS FOOT AMPUTATED, BUT ISSUES RELATED TO HIS PACEMAKER PREVENTED SURGERY. THE CALLER STATED HER FATHER ENDED UP IN HOSPICE, AND LATER PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR MAX II IMPLANTABLE PULSE GENERATOR DXY 1280

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 4470/307679| 4471/201426