BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSIGNIA ULTRA

    MDR report key: 892756 · Received July 27, 2007

    Report

    Report Number
    2124215-2007-99681
    Event Type
    Death
    Date Received
    July 27, 2007
    Date of Event
    January 23, 2007
    Report Date
    July 24, 2007
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. AS OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION RELATED TO THIS EVENT AVAILABLE TO THE COMPANY AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED AS NECESSARY. ON JUNE 23, 2006, BOSTON SCIENTIFIC ISSUED A PHYSICIAN LETTER DESCRIBING VARIOUS CLINICAL BEHAVIORS ASSOCIATED WITH THE FAILURE OF A LOW VOLTAGE CAPACITOR THAT COULD COMPROMISE THERAPY DELIVERY. THIS DEVICE IS INCLUDED IN THE POPULATION OF AFFECTED DEVICES. 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS PART OF A LEGAL ACTION AND THE PATIENT PASSED AWAY. BOSTON SCIENTIFIC HAS NO SPECIFIC INFORMATION AS TO WHETHER THE DEVICE WAS INVOLVED IN THE PATIENT'S DEATH. THE DEVICE IS SUBJECT TO AN ADVISORY, LOW VOLTAGE CAPACITOR (C2; 6/23/2006).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA ULTRA IMPLANTABLE PULSE GENERATOR DXY 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death 4457| 4480