BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST JUDE MEDICAL

    MDR report key: 2511285 · Received March 23, 2012

    Report

    Report Number
    MW5024812
    Event Type
    Injury
    Date Received
    March 23, 2012
    Date of Event
    March 22, 2012
    Report Date
    March 23, 2012
    Manufacturer
    UNKNOWN
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A CT MYELOGRAM. PT HAS AN IMPLANTED NEUROSTIMULATOR. DURING THE FLUOROSCOPIC MYELOGRAM PORTION (NOT THE CT PORTION) PT'S NEUROSTIMULATOR MALFUNCTIONED, CAUSING EXTREME PAIN FROM HIGH ABDOMEN TO TIPS OF TOES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL NEUROSTIMULATOR LGW UNKNOWN 3851ANS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other MYELOGRAM