BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 15089970 · Received July 22, 2022

    Report

    Report Number
    2182207-2022-01428
    Event Type
    Injury
    Date Received
    July 22, 2022
    Date of Event
    April 7, 2022
    Report Date
    July 22, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389, SERIAL#: UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL#: UNKNOWN, PRODUCT TYPE: EXTENSION. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3389, SERIAL/LOT #: UNKNOWN, PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL/LOT #: UNKNOWN. AGE: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT: 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    KYLE T. MITCHELL, STEPHEN L. SCHMIDT, JEFFREY W. COONEY, WARREN M. GRILL, JENNIFER PETERS, SHERVIN RAHIMPOUR, HUI-JIE LEE, SIN-HO JUNG, SNEHA MANTRI, BURTON SCOTT, SHIVANAND P. LAD, DENNIS A. TURNER. INITIAL CLINICAL OUTCOME WITH BILATERAL, DUAL-TARGET DEEP BRAIN STIMULATION TRIAL IN PARKINSON DISEASE USING SUMMIT RC + S. RESEARCH HUMAN CLINICAL STUDIES JOURNAL. DOI: 10.1227/NEU.0000000000001957 BACKGROUND: DEEP BRAIN STIMULATION (DBS) IS AN EFFECTIVE THERAPY IN ADVANCED PARKINSON DISEASE (PD). ALTHOUGH BOTH SUBTHALAMIC NUCLEUS (STN) AND GLOBUS PALLIDUS (GP) DBS SHOW EQUIVALENT EFFICACY IN PD, COMBINED STIMULATION MAY DEMONSTRATE SYNERGISM. OBJECTIVE: TO EVALUATE THE CLINICAL BENEFIT OF STIMULATING A COMBINATION OF STN AND GP DBS LEADS AND TO DEMONSTRATE BIOMARKER DISCOVERY FOR ADAPTIVE DBS THERAPY IN AN OBSERVATIONAL STUDY. METHODS: WE PERFORMED A PILOT TRIAL (N = 3) OF IMPLANTING BILATERAL STN AND GP DBS LEADS, CONNECTED TO A BIDIRECTIONAL IMPLANTABLE PULSE GENERATOR (MEDTRONIC SUMMIT RC + S; NCT03815656, IDE NO. G180280). INITIAL 1-YEAR OUTCOME IN 3 PATIENTS INCLUDED UNIFIED PD RATING SCALE ON AND OFF MEDICATIONS, MEDICATION DOSAGE, HAUSER DIARY, AND RECORDED BETA FREQUENCY SPECTRAL POWER. RESULTS: COMBINED DBS IMPROVED PD SYMPTOM CONTROL, ALLOWING >80% LEVODOPA MEDICATION REDUCTION. THERE WAS A GREATER DECREASE IN OFF- MEDICATION MOTOR UNIFIED PD RATING SCALE WITH MULTIPLE ELECTRODES ACTIVATED (MEAN DIFFERENCE FROM OFF STIMULATION OFF MEDICATIONS 18.2, RANGE 25.5 TO 12.5) THAN EITHER STN ( 12.8, RANGE 20.5 TO 0) OR GP ALONE ( 9, RANGE 11.5 TO 4.5). COMBINED DBS RESULTED IN A GREATER REDUCTION OF BETA OSCILLATIONS IN STN IN 5/6 HEMISPHERES THAN EITHER SITE ALONE. ADVERSE EVENTS OCCURRED IN 2 PATIENTS, INCLUDING A SMALL CORTICAL HEMORRHAGE AND SEIZURE AT 24 HOURS POSTOPERATIVELY, WHICH RESOLVED SPONTANEOUSLY, AND EXTENSION WIRE SCARRING REQUIRING REVISION AT 2 MONTHS POSTOPERATIVELY. CONCLUSION: PATIENTS WITH PD PREFERRED COMBINED DBS STIMULATION IN THIS PRELIMINARY COHORT. FUTURE STUDIES WILL ADDRESS EFFICACY OF ADAPTIVE DBS AS WE FURTHER DEFINE BIOMARKERS AND CONTROL POLICY. REPORTED EVENTS: 1. IT WAS REPORTED THAT A PATIENT WHOM UNDERWENT BILATERAL DEEP BRAIN STIMULATION FOR PARKINSON'S DISEASE HAD ONE SMALL, DELAYED (24 HOURS) POSTOPERATIVE CORTICAL HEMORRHAGE (<(><<)>1CM DIAMETER) AT THE LEAD ENTRY POINT. THE SMALL HEMORRHAGE WAS NOT PRESENT ON INTRAOPERATIVE OR POSTOPERATIVE CT SCANS WITHIN 12 HOURS BUT PRESENT AFTER AN ISOLATED GENERALIZED SEIZURE AT 24 HOURS POSTOPERATIVELY. THE SUBJECT WAS PLACED ON LEVETIRACETAM FOR 3 MONTHS WITHOUT SEIZURE RECURRENCE. A POSTOPERATIVE SCAN AT 2 WEEKS SHOWED RESOLUTION OF THE HEMORRHAGE.  2. IT WAS REPORTED THAT A PATIENT WHOM UNDERWENT BILATERAL DEEP BRAIN STIMULATION FOR PARKINSON'S DISEASE DEVELOPED TIGHTNESS OF THEIR EXTENSIONS IN THEIR NECK AT 6 WEEKS POSTOPERATIVELY (RELATED TO THE BULKY, DUAL 40-CM FORKED EXTENSIONS NEEDED TO CONNECT 4 LEADS TO A SINGLE IMPLANTABLE NEUROSTIMULATOR (INS). FULLY TREATED BY EXTENSION REVISION SURGERY TO LONGER (60CM) EXTENSIONS. THE SUBJECT ALSO DEVELOPED POSTOPERATIVE UNILATERAL LEG DYSKINESIA OFF ALL MEDICATIONS, WHICH RESOLVED AFTER 2 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103156 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention