BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONICS SPINAL STIM.

    MDR report key: 1760678 · Received July 14, 2010

    Report

    Report Number
    MW5016723
    Event Type
    Injury
    Date Received
    July 14, 2010
    Manufacturer
    MEDTRONICS
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WENT FOR AN MRI, AND THE TECHNICIAN WOULD "NOT" STOP WHEN I TOLD HER I HAD A BURNING PAIN IN MY BACK. I NOW HAVE DAMAGE TO MY SPINE AND HIP FROM THE MRI. THE RADIOLOGIST WILL NOT TALK TO ME. I HAVE INCLUDED MORE INFO FOR YOU TO LOOK AT. THESE ARE THE SYMPTOMS THAT I HAVE RECEIVED AFTER HAVING THE MRI DONE AT YOUR OFFICE: PAIN DIRECTLY ON AND AROUND THE LEADS OF THE STIMULATOR. RADIATING PAIN IN MY HIPS, LOWER BACK AND MIDDLE BACK. LOSS OF URINATING STREAM; HARD TO GO, AND VERY WEAK STREAM¿TAKES FOREVER. LOSS OF STRENGTH IN MY LEGS; I FEEL VERY WEAK. CAN'T STAND FOR LONG. I HAVE CALLED MY PRIMARY CARE PHYSICIAN TO MAKE AN APPOINTMENT TO FIND OUT HOW MUCH DAMAGE THERE IS TO MY BACK FROM THIS MRI. FDA PUBLIC HEALTH NOTIFICATION, ISSUED (B)(6) 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONICS SPINAL STIM. SPINAL STIMULATOR LGW MEDTRONICS 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| R| S