BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN NEUROSTIMULATOR

    MDR report key: 5800098 · Received July 16, 2016

    Report

    Report Number
    3007566237-2016-02652
    Event Type
    Injury
    Date Received
    July 16, 2016
    Date of Event
    August 7, 2003
    Report Date
    July 15, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF PUBLICATION.

    Description of Event or Problem · 1

    MACIA, F., PERLEMOINE, C., COMAN, I., GUEHL, D., BURBAUD, P., CUNY, E., GIN, H., RIGALLEAU, V., TISON, F. PARKINSON'S DISEASE PATIENTS WITH BILATERAL SUBTHALAMIC DEEP BRAIN STIMULATION GAIN WEIGHT. MOVEMENT DISORDERS: OFFICIAL JOURNAL OF THE MOVEMENT DISORDER SOCIETY. 2004; 19(2), 206-12. DOI: 10.1002/MDS.10630 SUMMARY: WEIGHT, BODY MASS INDEX (BMI) AND ENERGY EXPENDITURE/ENERGY INTAKE (EE/EI) WAS STUDIED IN 19 PARKINSON'S DISEASE (PD) PATIENTS AFTER SUBTHALAMIC DEEP BRAIN STIMULATION (STN-DBS) VERSUS 14 NONOPERATED ONES. OPERATED PATIENTS HAD A SIGNIFICANT WEIGHT GAIN (WG, _ 9.7 _ 7 KG) AND BMI INCREASE (_ 4.7 KG/M2). THE FAT MASS WAS HIGHER AFTER STN-DBS. RESTING EE (REE; OFFDRUG/ON STIMULATION) WAS SIGNIFICANTLY DECREASED IN STN-DBS PATIENTS, WHILE THEIR DAILY ENERGY EXPENDITURE (DEI) WAS NOT SIGNIFICANTLY DIFFERENT. A SIGNIFICANT CORRELATION WAS FOUND AMONG WG, BMI INCREASE, AND PRE-OPERATIVE LEVODOPA-EQUIVALENT DAILY DOSE, THEIR REDUCTION AFTER STN-DBS, AND THE DIFFERENTIAL REE RELATED TO STIMULATION AND THE REE IN THE OFFDRUG/OFF STIMULATION CONDITION. IN CONCLUSION, STNDBS IN PD INDUCES A SIGNIFICANT WG ASSOCIATED WITH A REDUCTION IN REE WITHOUT DEI ADJUSTMENT. REPORTED EVENTS: 1 PATIENT WITH PARKINSON'S DISEASE HAD AN INFECTION OF THE NEUROSTIMULATOR, REQUIRING REMOVAL PLUS ANTIBIOTIC TREATMENT AND REIMPLANTATION 3 MONTHS LATER WITHOUT FURTHER COMPLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453732 UNKNOWN DEEP BRAIN NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention