BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 1015883 · Received March 16, 2008

    Report

    Report Number
    MW5005928
    Event Type
    Other
    Date Received
    March 16, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 16, 2008
    Manufacturer
    RIVER OAKS IMAGING
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SINCE 2006, I HAVE HAD 7 STENTS PLACED - 3 TO RESOLVE A FAILED BYPASS -. LAST STENT WAS 2008. ON THE FOLLOWING MONTH, I UNDERWENT AN MRI OF THE CERVICAL SPINE. THE TEST WAS VERY UNCOMFORTABLE AND I WAS UNABLE TO FOCUS WHEN LEAVING THE FACILITY. I EXPERIENCED SIGNIFICANT CHEST PAIN CENTRALIZED UNDER THE STERNUM MOST OF THE EVENING AND WAS UNABLE TO SLEEP THAT NIGHT DUE TO NIGHTMARES - WHICH I NEVER HAVE -. THE NEXT DAY, I HAVE NOT COMPLETELY RECOVERED. I WILL DO MY BEST TO AVOID AN MRI IN THE FUTURE. AS OF THREE DAYS LATER, I AM STILL HAVING SPORADIC CHEST PAIN, THOUGH NOT NEARLY AS INTENSE AS THE PAIN ON THAT DAYS. I SPOKE WITH MY CARDIOLOGIST OFFICE, THEY SAID THEY HAD NEVER HEARD OF ANYTHING LIKE THIS. I HAVE HAD SEVERAL NUCLEAR STRESS TESTS -- THEY HAVE ALL BEEN NEGATIVE. THIS INCLUDES THE FIRST WHICH WAS THE DAY BEFORE MY TRIP TO THE ER AND MY QUADRUPLE BYPASS. THE SECOND DID INDICATE A PROBLEM 3 MONTHS LATER -- NEEDED ONE STENT. THE THIRD STRESS TEST WAS NEGATIVE. ONE MONTH LATER, 3 STENTS WERE PLACED TO CORRECT A FAILED BYPASS. SINCE THEN, WE HAVE GONE FOR ANGIOGRAMS AS STRESS TESTS AREN'T VERY ACCURATE FOR ME. MAYBE MY BODY IS JUST A LITTLE STRANGE; BUT THE EPISODE AFTER THE MRI FELT JUST LIKE I NEEDED MORE STENTS -- MAYBE THE ONES I HAVE NOW WERE AFFECTED. IF THIS INFO HELPS, OR YOU HAVE ANY QUESTIONS FEEL FREE TO CONTACT ME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK * LNH RIVER OAKS IMAGING

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other