BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 5806625 · Received July 19, 2016

    Report

    Report Number
    3007566237-2016-02679
    Event Type
    Injury
    Date Received
    July 19, 2016
    Date of Event
    January 1, 2003
    Report Date
    July 19, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389. EVENT DATE IS APPROXIMATE. YEAR VALID. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DOSHI, P. K., CHHAYA, N. A., BHATT, M. A. BILATERAL SUBTHALAMIC NUCLEUS STIMULATION FOR PARKINSON'S DISEASE. NEUROL INDIA. 2003; 51(1): 43-48. HTTP://LIBCONTENT.MEDTRONIC.COM:2133/PUBMED/12865514 SUMMARY: HIGH FREQUENCY STIMULATION OF THE SUBTHALAMIC NUCLEUS (STN) IS KNOWN TO AMELIORATE THE SIGNS AND SYMPTOMS OF ADVANCED PARKINSON¿S DISEASE. WE STUDIED THE EFFECT OF HIGH FREQUENCY STN STIMULATION IN 23 PATIENTS. TWENTY-TREE PATIENT¿S SUFFERING FROM SEVERE PARKINSON¿S DISEASE (STAGES III-V ON HOEHN AND YAHR SCALE) AND PARTICULARLY BRADYKINESIA, RIGIDITY, LEVODOPA-INDUCED DYSKINESIAS UNDERWENT BILATERALIMPLANTATION OF ELECTRODES IN THE STN. PREOPERATIVE AND POST-OPERATIVE ASSESMENTS OF THESE PATIENT¿S AT 1, 3, 6, AND 12 MONTHS FOLLOW UP IN ¿ON¿ AND ¿OFF¿ DRUG CONDITIONS WAS CARRIED OUT USING UNIFIED PARKINSON¿S DISEASE RATING SCALE, HOEHN AND YAHR STAGING, ENGLAND ACTIVITIES OF DAILY LIVING SCORE AND VIDEO RECORDINGS. AFTER ONE YEAR OF ELECTRICAL STIMULATION OF THE STN, THE PATIENT¿S SCORES FOR ACTIVITIES OF DAILY LIVING AND MOTOR EXAMINATION SCORES (UNIFIED PARKINSON¿S DISEASE RATING SCALE PARTS II AND III) OFF MEDICATION IMPROVED BY 62% AND 61%RESPECTIVELY (P<(><<)>0.0005). THE SUBSCORES FOR THE AKINESIA RIGIDITY, TREMOR AND GAIT ALSO IMPROVED. (P<(><<)>0.0005). THE AVERAGE AGE LEVODOPA DOSE DECREASED FROM 813 MG TO 359 MG. THE COGNITIVE FUNCTIONS REMAINED UNCHANGED. TWO PATIENTS DEVELOPED DEVICE RELATED COMPLICATIONS AND TWO PATIENTS EXPERIENCED ABNORMAL WEIGHT GAIN. BILATERAL SUBTHALAMIC NUCLEUS STIMULATION IS AN EFFECTIVE TREATMENT FOR ADVANCED PARKINSON¿S DISEASE. IT REDUCES THE SEVERITY OF ¿OFF¿ PHASE SYMPTOMS, IMPROVES AXIAL SYMPTOMS AND REDUCES LEVODOPA REQUIREMENTS. THE REDUCTION IN LEVODOPA DOSE IS USEFUL IN CONTROLLING DRUG-INDUCED DYSKINESIAS. REPORTED EVENTS: 1 MALE PATIENT SUFFERING FROM SEVERE PARKINSON¿S DISEASE, AND PARTICULARLY BRADYKINESIA, RIGIDITY, AND LEVODOPA-INDUCED DYSKINESIAS UNDERWENT DEEP BRAIN STIMULATION AND DEVELOPED DEVICE-RELATED COMPLICATIONS. IT WAS NOTED THE DIABETIC PATIENT DEVELOPED ¿DOUBTFUL¿ INFECTION AT THE SCALP CONNECTOR SITE WHERE HE WAS HOSPITALIZED IMMEDIATELY AND SUCCESSFULLY TREATED WITH INTRAVENOUS ANTIBIOTICS; 1 MALE PATIENT SUFFERING FROM SEVERE PARKINSON¿S DISEASE, AND PARTICULARLY BRADYKINESIA, RIGIDITY, AND LEVODOPA-INDUCED DYSKINESIAS UNDERWENT DEEP BRAIN STIMULATION AND DEVELOPED DEVICE-RELATED COMPLICATIONS. IT WAS NOTED THE PATIENT INJURED HIMSELF OVER THE NEUROSTIMULATOR AND DEVELOPED BREACH IN THE SKIN EXPOSING THE DEVICE. THE DEVICE WAS EXPLANTED AND THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THE DEVICE WAS IMPLANTED ON THE RIGHT SIDE AFTER HEALING OF THE LEFT SIDE WOUND. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457332 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R