BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSAR MAX DR

    MDR report key: 835639 · Received April 6, 2007

    Report

    Report Number
    2124215-2007-99562
    Event Type
    Death
    Date Received
    April 6, 2007
    Date of Event
    February 14, 2007
    Report Date
    April 2, 2007
    Manufacturer
    *
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFO TO DETERMINE THAT THIS DEVICE BEHAVED IN THE MANNER DESCRIBED IN THE ADVISORY.

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC REC'D INFO THAT THIS DEVICE WAS PART OF A LEGAL ACTION, AND THE PT PASSED AWAY 16 MONTHS FOLLOWING IMPLANT. BOSTON SCIENTIFIC HAS NO SPECIFIC INFO AS TO WHETHER THE DEVICE WAS INVOLVED IN THE PT'S DEATH. THIS DEVICE WAS SUBJECT TO AN ADVISORY, PDM HERMETIC SEALING ADVISORY - SECOND POPULATION (01/21/2006).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death