BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSAR MAX DR

    MDR report key: 843059 · Received April 20, 2007

    Report

    Report Number
    2124215-2007-99575
    Event Type
    Death
    Date Received
    April 20, 2007
    Date of Event
    April 10, 2007
    Report Date
    April 13, 2007
    Manufacturer
    CLONMEL
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. EVENT CONCLUSION AS OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THERE IS NO ADD'L INFO RELATED TO THIS EVENT. BOSTON SCIENTIFIC WILL CONTINUE TO INVESTIGATE THE COMPLAINT, AND IF ADD'L INFO BECOMES AVAILABLE, THE EVENT WILL BE REOPENED. ON JANUARY 21, 2005, GUIDANT (NOW BOSTON SCIENTIFIC) ISSUED A PHYSICIAN COMMUNICATION REGARDING GRADUAL DEGRADATION THAT MAY OCCUR IN A HERMETIC SEALING COMPONENT, WHICH MAY RESULT IN PREMATURE BATTERY DEPLETION, INAPPROPRIATE ACCELEROMETER FUNCTION, OR A RESET MESSAGE. THIS MAY AFFECT CERTAIN DEVICES MANUFACTURED BEFORE DECEMBER 6, 2000. THIS DEVICE WAS MANUFACTURED BEFORE DECEMBER 6, 2000, AND IS INCLUDED IN THIS POPULATION. BOSTON SCIENTIFIC DOES NOT HAVE SUFFICIENT INFORMATION TO DETERMINE THAT THIS DEVICE BEHAVED IN THE MANNER DESCRIBED IN THE ADVISORY.

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS PART OF A LEGAL ACTION AND THE PATIENT PASSED AWAY FIVE YEARS FOLLOWING IMPLANT. BOSTON SCIENTIFIC HAS NO SPECIFIC INFORMATION AS TO WHETHER THE DEVICE WAS INVOLVED IN THE PATIENT'S DEATH. THE DEVICE WAS SUBJECT TO AN ADVISORY, PDM HERMETIC SEALING ADVISORY (1/21/2006).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR MAX DR IMPLANTABLE PULSE GENERATOR DXY CLONMEL 1270 *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death