BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 8007673 · Received October 25, 2018

    Report

    Report Number
    3007566237-2018-03144
    Event Type
    Malfunction
    Date Received
    October 25, 2018
    Date of Event
    August 2, 2018
    Report Date
    October 25, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. ENGEL, K., HUCKHAGEL, T., GULBERTI, A., PÖTTER-NERGER, M., VETTORAQZZI, E., HIDDING, U., CHOE, C., ZITTEL, S., BRAAB, H., LUDEWIG, P., SCHAPER, M., KRAJEWSKI, K., OEHLWEIN, C., MITTMANN, K., ENGEL, AK., GERLOFF, C., WESTPHAL, M., MOLL, CKE., BUHMANN, C., KÖPPEN, JA., HAMEL, W. TOWARDS UNAMBIGUOUS REPORTING OF COMPLICATIONS RELATED TO DEEP BRAIN STIMULATION SURGERY: A RETROSPECTIVE SINGLE-CENTER ANALYSIS AND SYSTEMATIC REVIEW OF THE LITERATURE. PLOS ONE. 2018;13(8):E0198529. DOI: 10.1371/JOURNAL.PONE.0198529 IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: BACKGROUND AND OBJECTIVE TO DETERMINE RATES OF ADVERSE EVENTS (AES) RELATED TO DEEP BRAIN STIMULATION (DBS) SURGERY OR IMPLANTED DEVICES FROM A LARGE SERIES FROM A SINGLE INSTITUTION. SOUND COMPARISONS WITH THE LITERATURE REQUIRE THE DEFINITION OF UNAMBIGUOUS CATEGORIES, SINCE THERE IS NO CONSENSUS ON THE REPORTING OF SUCH AES. PATIENTS AND METHODS 123 CONSECUTIVE PATIENTS (MEDIAN AGE 63 YRS; FEMALE 45.5%) TREATED WITH DBS IN THE SUBTHALAMIC NUCLEUS (78 PATIENTS), VENTROLATERAL THALAMUS, INTERNAL PALLIDUM, AND CENTRE MEDIAN-PARAFASCICULAR NUCLEUS (1) WERE ANALYZED RETROSPECTIVELY. BOTH MEAN AND MEDIAN FOLLOW-UP TIME WAS 4.7 YEARS (578 PATIENT-YEARS). AES WERE ASSESSED ACCORDING TO THREE UNAMBIGUOUS CATEGORIES: HEMORRHAGES INCLUDING OTHER INTRACRANIAL COMPLICATIONS BECAUSE THESE MIGHT LEAD TO NEUROLOGICAL DEFICITS OR DEATH, INFECTIONS AND SIMILAR AES NECESSITATING THE EXPLANTATION OF HARDWARE COMPONENTS AS THIS RESULTS IN THE INTERRUPTION OF DBS THERAPY, AND LEAD REVISIONS FOR VARIOUS REASONS SINCE THIS INVOLVES AN ADDITIONAL INTRACRANIAL PROCEDURE. FOR A SYSTEMATIC REVIEW OF THE LITERATURE AE RATES WERE CALCULATED BASED ON PRIMARY DATA PRESENTED IN 103 PUBLICATIONS. HETEROGENEITY BETWEEN STUDIES WAS ASSESSED WITH THE I2 STATISTIC AND ANALYZED FURTHER BY A RANDOM EFFECTS META-REGRESSION. PUBLICATION BIAS WAS ANALYZED WITH FUNNEL PLOTS. RESULTS SURGERY- OR HARDWARE-RELATED AES (23) AFFECTED 18 OF 123 PATIENTS (14.6%) AND RESOLVED WITHOUT PERMANENT SEQUELAE IN ALL INSTANCES. IN 2 PATIENTS (1.6%), SMALL HEMORRHAGES IN THE STRIATUM WERE ASSOCIATED WITH TRANSIENT NEUROLOGICAL DEFICITS. IN 4 PATIENTS (3.3%; 0.7% PER PATIENT-YEAR) IMPULSE GENERATORS WERE REMOVED DUE TO INFECTION. IN 2 PATIENTS ELECTRODES WERE REVISED (1.6%; 0.3% PER PATIENT-YEAR). THERE WAS NO LEAD MIGRATION OR SURGICAL REVISION BECAUSE OF LEAD MISPLACEMENT. AGE WAS NOT STATISTICALLY SIGNIFICANT DIFFERENT (P>0.05), BETWEEN PATIENTS AFFECTED BY AES OR NOT. AE RATES DID NOT DECLINE OVER TIME AND SIMILAR INCIDENCES WERE FOUND AMONG ALL PATIENTS (423) IMPLANTED WITH DBS SYSTEMS AT OUR INSTITUTION UNTIL DECEMBER 2016. A SYSTEMATIC LITERATURE REVIEW REVEALED THAT EXACT AE RATES COULD NOT BE DETERMINED FROM MANY STUDIES, WHICH COULD NOT BE ATTRIBUTED TO STUDY DESIGNS. AVERAGE RATES FOR INTRACRANIAL COMPLICATIONS WERE 3.8% AMONG STUDIES (PER-STUDY ANALYSIS) AND 3.4% FOR POOLED ANALYSIS OF PATIENTS FROM DIFFERENT STUDIES (PER-PATIENT ANALYSIS). ANNUAL HARDWARE REMOVAL RATES WERE 3.6 AND 2.4% FOR PER-STUDY AND PER-PATIENT ANALYSIS, RESPECTIVELY, AND LEAD REVISION RATES WERE 4.1 AND 2.6%, RESPECTIVELY. THERE WAS SIGNIFICANT HETEROGENEITY BETWEEN STUDIES (I2 RANGED BETWEEN 77% AND 91% FOR THE THREE CATEGORIES; P< 0.0001). FOR HARDWARE REMOVAL HETEROGENEITY (I2 = 87.4%) WAS REDUCED BY TAKING STUDY SIZE (P<(><<)> 0.0001) AND PUBLICATION YEAR (P< 0.01) INTO ACCOUNT, ALTHOUGH A SIGNIFICANT DEGREE OF HETEROGENEITY REMAINED (I2 = 80.0%; P< 0.0001). BASED ON COMPARISONS WITH HEALTH CARE-RELATED DATABASES THERE APPEARS TO BE PUBLICATION BIAS WITH LOWER RATES FOR HARDWARE-RELATED AES IN PUBLISHED PATIENT COHORTS. CONCLUSIONS THE PROPOSED CATEGORIES ARE SUITED FOR AN UNEQUIVOCAL ASSESSMENT OF AES EVEN IN A RETROSPECTIVE MANNER AND USEFUL FOR BENCHMARKING. AE RATES IN THE PRESENT COHORTS FROM OUR INSTITUTION COMPARE FAVORABLY WITH THE LITERATURE. REPORTED EVENTS: A PATIENT WITH VENTRAL INTERMEDIATE NUCLEUS OF THE THALAMUS (VIM) DBS HAD A SUBOPTIMALLY PLACED LEAD BUT REFUSED REVISION SURGERY. ALL PATIENTS WERE REPORTEDLY IMPLANTED WITH EITHER 37601, 7428, 7426, 37612, OR 37602/37603 MODEL NEUROSTIMULATORS, AND MODEL 3389 LEADS. IT WAS NOT POSSIBLE TO ASCERTAIN ANY ADDITIONAL 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
    844582 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR