BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 852668 · Received May 8, 2007

    Report

    Report Number
    2182207-2007-01593
    Event Type
    Other
    Date Received
    May 8, 2007
    Report Date
    April 19, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE REPORTED, A CHANGE IN TISSUE AFTER A MRI HEAD SCAN. THE PT'S LEADS WERE IMPLANTED IN THE STN OF BOTH HEMISPHERES FOR PARKINSONS. THE HCP ORDERED A MRI. THE REASON FOR MRI IS UNK; AT THE TIME, THE PT WAS NOT HAVING ANY ISSUES WITH THE DEVICE AND WAS RECEIVING GOOD THERAPY. THE DEVICE WAS TURNED OFF FOR THE MRI SCAN. AFTER THE SCAN WAS COMPLETE, THE PT DID NOT APPEAR TO HAVE ANY PROBLEMS SO THEY WENT HOME WITHOUT BEING SEEN BY THE HCP. A DAY OR SO LATER, THE PT RETURNED TO THE CLINIC WITH TREMOR ONLY ON SIDE; PRIOR, THE PT HAD PARKINSONIAN SYMPTOMS ON BOTH SIDES. THE HCP TURNED THE DEVICES BACK ON FOR BOTH HEMISPHERES AND THE PT'S SYMPTOMS WENT AWAY ON THE SIDE THAT HAD TREMOR. THE HCP ORDERED CT SCAN AND OBSERVED SOME PHYSICAL CHANGE OF THE TISSUE AT THE END OF THE LEAD ON THE PT'S SIDE WHERE THEY SAW THE SYMPTOM IMPROVEMENT WITH THE DEVICE TURNED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN UNK MHY MEDTRONIC NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other EXPLANTED:| IMPLANTED:| IMPLANTABLE NEUROSTIMULATOR MODEL UNK LOT# UNK