BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATOR

    MDR report key: 1069549 · Received July 3, 2008

    Report

    Report Number
    2182207-2008-03757
    Event Type
    Injury
    Date Received
    July 3, 2008
    Report Date
    June 5, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: LOHMANN E, WELTER M-L, ET AL. ARE PARKIN PATIENTS PARTICULARLY SUITED FOR DEEP-BRAIN STIMULATION MOV DISORD. 2008; 23(5): 740-743. PATIENTS WITH PARKIN MUTATIONS ARE KNOWN TO HAVE SLOWER PD PROGRESSION AND A BETTER RESPONSE TO LEVODOPA AT LOWER DOSES THAN PATIENTS WITH IDIOPATHIC PARKINSON'S DISEASE. TO DETERMINE THE EFFECTS OF DEEP BRAIN STIMULATION (DBS) ON SUCH PATIENTS, WE HAVE COMPARED THE FOLLOW-UP AFTER SURGERY OF 7 PATIENTS WITH ONE PARKIN MUTATION, 7 PATIENTS WITH TWO PARKIN MUTATIONS, AND 39 PATIENTS WITHOUT PARKIN MUTATIONS. TWELVE TO 24 MONTHS AFTER BILATERAL STN STIMULATION NEUROSURGERY, THE DAILY DOSES OF LEVODOPA EQUIVALENT WERE SIGNIFICANTLY LOWER IN PATIENTS WITH TWO PARKIN MUTATIONS, INDICATING THAT THESE PATIENTS BENEFIT FROM DBS, AND THEY MIGHT HAVE MORE DURABLE RESULTS. REPORTABLE EVENT: ONE COMPLICATION WAS NOTED AT 12 MONTH FOLLOW-UP. ONE OF THE PATIENTS WITH TWO PARKIN MUTATIONS EXPERIENCED A SEVERE ATYPICAL BALLISTIC DYSKINESIA IN THE LEGS AFTER SURGERY, REMINISCENT OF SIMILAR COMPLICATIONS IN SOME PD PATIENTS WHO UNDERWENT NEURAL TRANSPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other PROGRAMMER MODEL UNK N=1| EXTENSION MODEL UNK N=2| LEAD MODEL UNK N=2