BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 15514820 · Received September 30, 2022

    Report

    Report Number
    2182207-2022-01830
    Event Type
    Injury
    Date Received
    September 30, 2022
    Date of Event
    July 15, 2022
    Report Date
    September 29, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Description of Event or Problem · 0

    RYOONG HUH, MOONYOUNG CHUNG, IL JANG. OUTCOME OF PALLIDAL DEEP BRAIN STIMULATION FOR TREATING ISOLATED OROFACIAL DYSTONIA. JOURNAL ACTA NEUROHCIRURGICA. DOI: 10.1007/S00701-022-05320-9. BACKGROUND ISOLATED OROFACIAL DYSTONIA IS A RARE SEGMENTAL NEUROLOGICAL DISORDER THAT AFFECTS THE EYE, MOUTH, FACE, AND JAWS. CURRENT LITERATURE ON PALLIDAL SURGERY FOR OROFACIAL DYSTONIA IS LIMITED TO CASE REPORTS AND SMALL-SCALE STUDIES. THIS STUDY WAS TO INVESTIGATE CLINICAL OUTCOMES OF DEEP BRAIN STIMULATION (DBS) OF THE GLOBUS PALLIDUS INTERNUS (GPI) IN PATIENTS WITH ISOLATED OROFACIAL DYSTONIA. METHODS THIRTY-SIX PATIENTS WHO UNDERWENT GPI DBS AT INCHEON ST. MARY¿S HOSPITAL, THE CATHOLIC UNIVERSITY OF KOREA, BETWEEN 2014 AND 2019 WERE INCLUDED IN THIS STUDY. BURKE-FAHN-MARSDEN DYSTONIA RATING SCALE, UNIFIED DYSTONIA RATING SCALE, AND GLOBAL DYSTONIA SEVERITY RATING SCALE WERE RETROSPECTIVELY RETRIEVED FOR ANALYSIS BEFORE SURGERY, AT 6-MONTH FOLLOW-UP AS SHORT-TERM OUTCOME, AND AT FOLLOW-UP OVER 1 YEAR (12 MONTHS TO 69 MONTHS) AS LONG-TERM RESULTS. RESULTS MEAN TOTAL BFMDRS-M SCORES AT THE THREE TIME POINTS (BASELINE, 6 MONTHS, AND OVER 1 YEAR FOLLOW-UP) WERE 11.6 ± 4.9, 6.1 ± 5.2 (50.3 ± 29.9% IMPROVEMENT, P <(><<)> 0.05), AND 4.3 ± 4.2 (65.0 ± 24.2% IMPROVEMENT, P <(><<)> 0.05), RESPECTIVELY. IN TERMS OF UDRS AND GDS, IMPROVEMENT RATES WERE 45.1% (P <(><<)> 0.001) AND 47.7% (P <(><<)> 0.001) AT 6 MONTHS, AND 63.8% (P <(><<)> 0.001) AND 65.7% (P <(><<)> 0.001) AT OVER 1 YEAR AFTER SURGERY, RESPECTIVELY. CONCLUSIONS BILATERAL GPI DBS IN ISOLATED OROFACIAL DYSTONIA CAN BE EFFECTIVE IF CONSERVATIVE TREATMENT OPTION FAILS. ITS BENEFIT IS NOT ONLY OBSERVED IN A SHORT TERM, BUT ALSO MAINTAINED IN A LONG-TERM FOLLOW-UP. REPORTED EVENTS: 1-2: IT WAS REPORTED THAT A PATIENT UNDERWENT BILATERAL GPI DBS IMPLANTATION AND EXPERIENCED INTRACRANIAL HEMORRHAGE THERE WAS ALSO SEROMATOUS FLUID FILLING AND LEAKAGE IN THEIR INS INSERTION SITE 1 YEAR AFTER SURGERY. IT WAS COMPLETELY CURED WITHOUT REMOVING THE EXISTING IMPLANTED DEVICE WITH REVISION SURGERY AND ANTIBIOTICS. 3: IT WAS REPORTED THAT A PATIENT UNDERWENT BILATERAL GPI DBS IMPLANTATION AND EXPERIENCED INTRACRANIAL HEMORRHAGE AFTER SURGERY IN 2019. THE SYMPTOMS OF INVOLUNTARY MUSCULAR CONTRACTION THAT DESCENDED FROM THE FOREHEAD TO THE MAXILLARY REGION PERSISTED AND DESPITE SEVERAL OUTPATIENT VISITS FOR THE PARAMETER ADJUSTMENT ADDITIONAL SCALP DISCOMFORT AROUND THE BILATERAL ELECTRODE INSERTION AREA WAS AGGRAVATED. IMPROVEMENT RATE IN BFMDRS WAS LITTLE COMPARED TO PREOPERATIVE STATUS AND THE PATIENT REQUESTED TO HAVE BOTH ELECTRODES REMOVED. 4: IT WAS REPORTED THAT 4 PATIENTS UNDERWENT BILATERAL GPI DBS IMPLANTATION AND EXPERIENCED INTRACRANIAL HEMORRHAGE. BOTH PATIENTS HAD SHOWN RELATIVELY SMALL AMOUNTS OF BLEEDING ( 1CC AT THE LEFT PUTAMEN IN ONE PATIENT; 0.5CC AT RIGHT FRONTAL SUBCORTICAL AREA IN ANOTHER PATIENT). THE OTHER TWO SHOWED IMPROVEMENT RATES OF 29% AND 21.4% RESPECTIVELY AND BLEEDING MEASUREMENTS WERE 4CC AT RIGHT SUBCORTICAL AREA IN ONE PATIENT AND 10CC IN THE OTHER. IT WAS NOT POSSIBLE TO ASCERTAIN 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
    1886449 IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown Required Intervention