BEUDAMED
    FDA Adverse Event Other Summary report: N

    ST JUDE MEDICAL

    MDR report key: 2877914 · Received December 11, 2012

    Report

    Report Number
    MW5028182
    Event Type
    Other
    Date Received
    December 11, 2012
    Date of Event
    June 14, 2012
    Report Date
    December 11, 2012
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A NEUROSTIMULATOR WAS IMPLANTED FOR INTRACTABLE MIGRAINES BY DR (B)(6) ON (B)(6) 2012. APPROX (B)(6) DAYS LATER OF USING THE NEUROSTIMULATOR, I EXPERIENCED SEVERE, CRIPPLING ANXIETY AND PANIC ATTACKS WHILE THE DEVICE WAS TURNED ON. I CONTINUED TO USE THE DEVICE AS DIRECTED AND PANIC ATTACKS AND ANXIETY STILL OCCURRED. I REQUESTED THE DEVICE TO BE REMOVED ON (B)(6) 2012. I NOW SUFFER FROM PANIC DISORDER AND ALSO SEVERE DEPRESSION. I ALSO EXPERIENCED THE ANXIETY SENSATION DURING THE TRIAL STIMULATOR IMPLANT DONE BY DR (B)(6), BUT DIDN'T ACKNOWLEDGE WHAT IT WAS AT THE TIME BECAUSE I HAD NEVER EXPERIENCED A PANIC ATTACK SO INTENSE. I WAS TOLD THE ONLY BAD THING THAT COULD HAPPEN WAS THAT MY BODY COULD REJECT THE EQUIPMENT AND WOULD GET AN INFECTION AND HAVE TO HAVE THE NEUROSTIM REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other