BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSIGNIA ULTRA

    MDR report key: 793113 · Received December 8, 2006

    Report

    Report Number
    2124215-2006-99522
    Event Type
    Death
    Date Received
    December 8, 2006
    Date of Event
    September 27, 2006
    Report Date
    December 7, 2006
    Manufacturer
    CLONMEL
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    H6 - NOT RETURNED. EVENT CONCLUSION: THE PT WAS CREMATED AND THE FIELD REP THOUGHT THE DEVICE WOULD HAVE BEEN EXPLANTED, BUT HAS NOT BEEN RETURNED AS OF YET. IF THE DEVICE IS RETURNED ANALYSIS SHOULD BE PERFORMED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFO BECOMES AVAILABLE OR IF THE DEVICE IS RETURNED, THE EVENT WILL BE OPENED.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: BOSTON SCIENTIFIC RECEIVED INFO THAT THIS PT'S FAMILY RETURNED PT VERIFICATION FORM WITH THE PT'S DEATH CERTIFICATE, WHICH STATED THAT THE CAUSE OF DEATH WAS : A) IMMEDIATE CAUSE: CARDIORESPIRATORY FAILURE. B) DUE TO OR AS A CONSEQUENCE OF: PACEMAKER DYSFUNCTION. C) DUE TO OR AS A CONSEQUENCE OF: LEAD PERFORATION. THE DATE OF DEATH WAS NOTED AS 2006. NO AUTOPSY WAS PERFORMED, AND IT IS NOTED THAT THE PT WAS CREMATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death 4087| 4086