BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 8095300 · Received November 21, 2018

    Report

    Report Number
    3007566237-2018-03386
    Event Type
    Injury
    Date Received
    November 21, 2018
    Date of Event
    August 14, 2018
    Report Date
    November 21, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. CONTINUATION OF MEDICAL DEVICES: PRODUCT ID 3389. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3389. KIM, M., CHO, KR., PARK, JH., AHN, JH., CHO, JH., PARK,S., LEE, JI., YOUN, J. BILATERAL SUBTHALAMIC DEEP BRAIN STIMULATION IS AN EFFECTIVE AND SAFE TREATMENT OPTION FOR THE OLDER PATIENTS WITH PARKINSON'S DISEASE. CLIN NEUROL NEUROSURG. 2018;173:182-186. DOI: 10.1 016/J.CLINEURO.2018.08.025. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: OBJECTIVES: WE AIMED TO PROVIDE EVIDENCE THAT SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) IS AN EFFECTIVE AND SAFE TREATMENT OPTION FOR OLDER PATIENTS WITH PARKINSON¿S DISEASE (PD). PATIENTS AND METHODS: BILATERAL STN DBS WAS PERFORMED IN 55 PATIENTS WITH PD FROM 2012 TO 2016 AT (B)(6) MEDICAL CENTER. WE DIVIDED THEM INTO TWO GROUPS BASED ON THE AGE AT DBS: YOUNGER GROUP (<(><<)> 65 YEARS, N=38) AND OLDER GROUP (=65 YEARS, N=17). FOR EVALUATING EFFECTIVENESS, WE COMPARED PRE- AND POST-DBS UNIFIED PARKINSON¿S DISEASE RATING SCALE (UPDRS) PART 3 AND 4 SCORES AND LEVODOPA EQUIVALENT DAILY DOSE (LEDD) BETWEEN THE TWO GROUPS. ADDITIONALLY, SURGERY-RELATED COMPLICATIONS IN EACH GROUP WERE ASSESSED. RESULTS: THE MEAN AGE OF THE YOUNGER GROUP WAS 56.7 ± 5.7 AND THAT OF THE OLDER GROUP WAS 68.5 ± 2.9. MORE FEMALE PATIENTS UNDERWENT STN DBS IN THE YOUNGER GROUP, BUT THERE WERE NO DIFFERENCES IN BASELINE CHARACTERISTICS. IN TERMS OF EFFECTIVENESS, UPDRS PART 3 AND 4 SCORES AND LEDD SIGNIFICANTLY IMPROVED 6 MONTHS AFTER DBS IN BOTH GROUPS. IN TERMS OF SAFETY, 1 COMPLICATION WAS OBSERVED IN THE YOUNGER GROUP (2.6%), WHILE 2 COMPLICATIONS, INCLUDING 1 SUBJECT WITH INTRACEREBRAL HEMORRHAGE, WERE OBSERVED IN THE OLDER GROUP (11.8%, P=0.225). CONCLUSION: BASED ON OUR RESULTS, STN DBS CAN BE APPLIED IN WELL-SELECTED OLDER PATIENTS WITH PD AS WELL AS IN YOUNGER PATIENTS. HOWEVER, DESPITE THE LACK OF STATISTICAL SIGNIFICANCE, MORE ATTENTION SHOULD BE PAID ON SURGICAL COMPLICATIONS IN THE OLDER GROUP. REPORTED EVENTS: PLI 10: 2 PATIENTS WITH BILATERAL SUBTHALAMIC NUCLEUS (STN)-DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE (PD) EXPERIENCED SURGERY RELATED TRANSIENT PSYCHOSIS. PLI 20: A (B)(6) MAN RECEIVING BILATERAL STN-DBS FOR PD EXPERIENCED HIGH SYSTOLIC BLOOD PRESSURE THAT COULD NOT BE CONTROLLED WITH INTRAVENOUS INJECTION OF BLOOD PRESSURE LOWERING AGENTS AND ULTIMATELY AN INTRACEREBRAL HEMORRHAGE IN THE LEFT MIDBRAIN AND THALAMUS LED THE SURGEONS TO SUSPEND THE IMPLANT PROCEDURE. THE HEMORRHAGE WAS ASSOCIATED WITH TRANSIENT RIGHT-SIDE WEAKNESS AND DYSARTHRIA. ALL PATIENTS WERE IMPLANTED WITH MODEL 3389 LEADS. IT WAS NOT POSSIBLE TO ASCERTAIN ANY OTHER SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936707 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other