BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 11180156 · Received January 15, 2021

    Report

    Report Number
    2182207-2021-00083
    Event Type
    Injury
    Date Received
    January 15, 2021
    Date of Event
    November 2, 2020
    Report Date
    January 15, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    KOCABICAK E, O YI, AYGUN D, TEMEL Y. EFFECTS OF DEEP BRAIN STIMULATION OF THE SUBTHALAMIC NUCLEUS ON THE POSTOPERATIVE LEVODOPA RESPONSE: ONE YEAR FOLLOW UP. TURK NEUROSURG. 2020. 10.5137/1019-5149.JTN.30065-20. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. 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. . OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ASKU. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ASKU. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ASKU. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: TO INVESTIGATE THE EFFECT OF PREOPERATIVE LEVODOPA RESPONSIVENESS TO CLINICAL OUTCOMES IN THE FIRST POSTOPERATIVE YEAR, AND TO EVALUATE THE CHANGES IN THE POSTOPERATIVE LEVODOPA RESPONSIVENESS IN PATIENTS UNDERGOING SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS). FORTY-NINE PARKINSON¿S DISEASE (PD) PATIENTS UNDERGOING BILATERAL DBS OF THE STN WERE INCLUDED IN THIS STUDY. THEIR CLINICAL MOTOR SYMPTOMS WERE ASSESSED PREOPERATIVELY BY UPDRS PART III SCORE IN BOTH OFF AND ON MEDICATION STATES. POSTOPERATIVELY, THE ASSESSMENTS WERE OBTAINED IN THREE CONSECUTIVE CONDITIONS. PREOPERATIVELY AND POSTOPERATIVELY, THE PERCENTAGE DIFFERENCE BETWEEN THESE TWO SCORES WAS EVALUATED AS LEVODOPA RESPONSE. MEAN AGE WAS 54.6 ± 9 YEARS (27¿70). LEVODOPA RESPONSE SIGNIFICANTLY DECREASED POSTOPERATIVELY BY 56% A YEAR. COMPARED WITH PREOPERATIVE MED ON AND POSTOPERATIVE STIM ON / MED ON SCORES, THE CLINICAL RESULTS OF THE FIRST YEAR WERE OBTAINED AND AN IMPROVEMENT OF 25% ON THE UPDRS 3 SCORE WAS OBSERVED. COMPARED WITH PREOPERATIVE LEVODOPA RESPONSE AND CLINICAL OUTCOMES, BETTER CLINICAL RESULTS WERE OBTAINED IN PATIENTS WITH HIGHER PREOPERATIVE LEVODOPA RESPONSE (P < 0.05). IN THIS STUDY, THE AUTHORS CONFIRM THAT THE RESPONSE OF L-DOPA DECREASES AFTER DBS OF THE STN. THE REASONS FOR THIS FINDING ARE NOT CLEAR. HOWEVER, DBS OF THE STN ALLOWS FOR THE REDUCTION OF PD MEDICATIONS AND IMPROVEMENT OF DAILY LIFE ACTIVITIES, MOTOR FUNCTION, MOTOR FLUCTUATIONS, AND DYSKINESIA. REPORTED EVENTS: ONE PATIENT EXPERIENCED POST-OPERATIVE LEFT FRONT CORTICAL HEMORRHAGE, WHICH DID NOT REQUIRE SURGERY AND DID NOT LEAVE PERMANENT SEQUELAE. TWO PATIENTS EXPERIENCED POST-OPERATIVE LOCAL INFECTION. THE PATIENTS WERE TREATED WITH ANTIBIOTICS AND DID NOT REQUIRE EXPLANT. TWO PATIENTS EXPERIENCED POST-OPERATIVE PSYCHOSIS. THE PATIENTS WERE MANAGED WITH PSYCHIATRIC MEDICAL TREATMENT AND ALTERING STIMULATION SETTINGS. TWO PATIENTS EXPERIENCED POST-OPERATIVE HYPOMANIA. THE PATIENTS WERE MANAGED WITH PSYCHIATRIC MEDICAL TREATMENT AND ALTERING STIMULATION SETTINGS. THE PATIENTS WERE IMPLANTED WITH BILATERAL SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE. SPECIFIC DEVICE INFORMATION COULD NOT BE IDENTIFIED FROM THE LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76218 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1