BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST JUDE MEDICAL

    MDR report key: 1133884 · Received August 26, 2008

    Report

    Report Number
    MW5008070
    Event Type
    Injury
    Date Received
    August 26, 2008
    Date of Event
    June 1, 2008
    Report Date
    August 26, 2008
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAS EXPERIENCED ELECTRO-MAGNETIC INTERFERENCE. FOR EXAMPLE, WHEN SHE USES THE PHONE HER EAR BECOMES RED. WHEN SHE IS BY MACHINES, SHE GETS SICK. SHE CANNOT WORK HER REGULAR SCHEDULE, YESTERDAY SHE HAD A FAINTING SPELL. SHE IS ALSO SWEATING AND HER HEAD IS SPINNING. THE DR DOESN'T WANT TO DO ANYTHING TO TREAT HER. HE SAYS IT IS CRAZINESS. PT HAS BEEN TO THE EMERGENCY MULTIPLE TIMES WITH PALPITATIONS. SHE HAS BEEN HOSPITALIZED. THE AMBULANCE HAS COME FOR HER 3 TIMES BUT DR SENDS HER HOME. PT SAYS SHE CAN'T TOUCH THE MICROWAVE, PHONE OR TV. SHE GETS A BURNING SENSATION. HER BLOOD PRESSURE IS GETTING HIGHER AND HER MEDICATION HAS BEEN INCREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL PACEMAKER DXY ST JUDE MEDICAL 5376

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability