BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 1100554 · Received August 5, 2008

    Report

    Report Number
    MW5007900
    Event Type
    Injury
    Date Received
    August 5, 2008
    Date of Event
    September 7, 2006
    Report Date
    July 2, 2008
    Manufacturer
    GUIDANT CORP.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ITCHING SKIN, RASH, BROWN MOLES, BLOODY BLISTERS OVER ENTIRE BODY. DISCOLORATION OF SKIN AND RASH ON NECK AND CHEST. NECK AND HEAD PAIN ON LEFT SIDE OF BODY. DAILY HEARTBURN, DAILY UPSET STOMACH, LOSS OF WEIGHT, LACK OF SLEEP AND TOTAL FATIGUE. PLEASE NOTE: SKIN ALLERGIES STARTED TO APPEAR TWO DAYS AFTER PACEMAKER IMPLANT. DATES OF USE: 2006. DIAGNOSIS OR REASON FOR USE: IRREGULAR HEART BEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL HEART PACEMAKER DXY GUIDANT CORP. XLDR MODEL 5386
    2 GUIDANT LEAD DTB GUIDANT CORP. 4054

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O| S IMPLANT| GUIDANT LEAD 4054