BEUDAMED
    FDA Adverse Event Death Summary report: N

    UTERINE ARTERY EMBOLIZATION

    MDR report key: 950917 · Received November 20, 2007

    Report

    Report Number
    MW5004443
    Event Type
    Death
    Date Received
    November 20, 2007
    Date of Event
    October 25, 2007
    Report Date
    November 30, 2007
    Product Code
    NAJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WOMAN DIED THE WEEK OF UAE PROCEDURE. DEATH IS REPORTED BY A FRIEND. "THE PROCEDURE WAS STOPPED MID WAY THROUGH AS HER BREATHING HAD BECOME VERY DIFFICULT." FRIEND WAS TOLD THAT EMBOLIC MATERIAL MIGRATED TO THE LUNGS. TWO DAYS LATER, SHE DIED.

    Description of Event or Problem · 1

    THIS REPORT IS TO UPDATE THE DATE OF DEATH WHICH WAS NOT IN THE PREVIOUS REPORT. IT IS A REQUEST TO OPEN THE INVESTIGATION FOR THE GUIDANT ISSUE, THAT I HAVE BEEN DEALING WITH CONCERNING THE MALFUNCTION OF THE GUIDANT DEVICE AND THIS RECORD WILL UPDATE YOU CONCERNING THE EARLIER INVESTIGATION BY FDA. CONDUCTED AND A LETTER WAS SENT TO (B)(6), AFTER COMPLETING AN INVESTIGATION. THE DEVICE WAS SENT FOR ANALYSIS, AND A NEW ONE WAS PLACED IN, BECAUSE MY SAFETY WAS JEOPARDIZED. THE MEDTRONIC DEVICE NOW IS A WORKING FUNCTIONING DEVICE ACCORDING TO DR (B)(6). THE GUIDANT'S MISFIRING HAD EFFECTED MY HEART FUNCTION. I WOULD --- THAT THE CASE BE RE EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UTERINE ARTERY EMBOLIZATION NONE NAJ

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death