BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 8007653 · Received October 25, 2018

    Report

    Report Number
    3007566237-2018-03143
    Event Type
    Injury
    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
    Adverse Event
    Yes
    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. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN; PRODUCT ID: 3389, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL/LOT #: UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    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: (I) HEMORRHAGES INCLUDING OTHER INTRACRANIAL COMPLICATIONS BECAUSE THESE MIGHT LEAD TO NEUROLOGICAL DEFICITS OR DEATH, (II) INFECTIONS AND SIMILAR AES NECESSITATING THE EXPLANTATION OF HARDWARE COMPONENTS AS THIS RESULTS IN THE INTERRUPTION OF DBS THERAPY, AND (III) 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 60-YEAR-OLD PATIENT WITH SUBTHALAMIC NUCLEUS (STN)-DEEP BRAIN STIMULATION (DBS) HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) EXPLANTED 3-MONTHS AFTER IMPLANT DUE TO STAPHYLOCOCCUS AUREUS INFECTION. A RISK FACTOR NOTED BY THE AUTHORS WAS DIABETES MELLITUS. THEY WERE LATER REIMPLANTED. THE EVENT WAS REPORTEDLY REVERSIBLE/ RESOLVED WITHOUT PERMANENT SEQUELAE. A 64-YEAR OLD PATIENT WITH STN-DBS HAD THEIR SYSTEM COMPLETELY EXPLANTED 10-MONTHS AFTER IMPLANT DUE TO PURULENT INFECTION. THEY NOTED THAT THE INS WAS NOT REIMPLANTED DESPITE THE FACT THAT THE PATIENT HAD GOOD CLINICAL EFFECT. THE EVENT WAS REPORTEDLY REVERSIBLE/RESOLVED WITHOUT PERMANENT SEQUELAE. A 69-YEAR-OLD PATIENT WITH STN-DBS HAD THEIR DEVICE EXPLANTED MULTIPLE TIMES DUE TO REPEATED INFECTIONS AT DIFFERENT INS SITES, THE FIRST OF WHICH OCCURRED 22-MONTHS AFTER IMPLANT. THEY WERE REPORTEDLY REIMPLANTED TWICE. THE EVENT WAS REPORTEDLY REVERSIBLE/RESOLVED WITHOUT PERMANENT SEQUELAE. A PATIENT WITH STN-DBS HAD THEIR INS REVISED 19-MONTHS AFTER IMPLANT FOR SUB-MUSCULAR PLACEMENT. THE EVENT REPORTEDLY RESOLVED WITHOUT PERMANENT SEQUELAE. A 70-YEAR-OLD PATIENT WITH STN-DBS REQUIRED HARDWARE REMOVAL 34-MONTHS AFTER IMPLANT DUE TO CHRONIC INFLAMMATION, NON-PURULENT INFECTIOUS ULCERATION/EROSION. THEY WERE LATER REIMPLANTED. THE EVENT REPORTEDLY RESOLVED WITHOUT PERMANENT SEQUELAE. 2 PATIENTS WITH DBS EXPERIENCED NON-PURULENT CHRONIC INFLAMMATION THAT RESULTED IN EROSION AND REQUIRED HARDWARE REMOVAL. A PATIENT WITH DBS EXPERIENCED MECHANICAL EROSION AT THE INS SITE CAUSED BY BACKPACKING THAT REQUIRED HARDWARE REMOVAL. 2 PATIENTS WITH DBS EXPERIENCED NON-PURULENT INFECTIONS/CHRONIC INFLAMMATION THAT RESULTED IN EROSION BETWEEN 17 AND 32 MONTHS PO ST-IMPLANT AND REQUIRED HARDWARE REMOVAL. THE EVENT REPORTEDLY RESOLVED WITHOUT PERMANENT SEQUELAE. A PATIENT WITH STN-DBS HAD A LOCAL REVISION OF THE FRONTAL WOUND 3 WEEKS AFTER IMPLANT RELATED TO UNSPECIFIED WOUND COMPLICATIONS OR WOUND HEALING. THE EVENT REPORTEDLY RESOLVED WITHOUT PERMANENT SEQUELAE. A PATIENT WITH GPI-DBS REQUIRED RETROAURICULAR DEBRIDEMENT 4 MONTHS AFTER IMPLANT RELATED TO UNSPECIFIED WOUND COMPLICATIONS OR WOUND HEALING. THE EVENT REPORTEDLY RESOLVED WITHOUT PERMANENT SEQUELAE. A PATIENT WITH GPI-DBS REQUIRED A LOCAL REVISION OF THE INS SITE 2 WEEKS AFTER IMPLANT RELATED TO UNSPECIFIED WOUND COMPLICATIONS OR WOUND HEALING. THE EVENT REPORTEDLY RESOLVED WITHOUT PERMANENT SEQUELAE. A PATIENT WITH DBS OF THE CENTRE MÉDIAN-PARAFASCICULAR (CM-PF) COMPLEX REQUIRED A LOCAL REVISION OF THE INS SITE 3 WEEKS AFTER IMPLANT RELATED TO UNSPECIFIED WOUND COMPLICATIONS OR WOUND HEALING. THE EVENT REPORTEDLY RESOLVED WITHOUT PERMANENT SEQUELAE. A PATIENT WITH STN-DBS UNDERWENT LEAD REPLACEMENT 1-WEEK AFTER IMPLANT BECAUSE OF LOW IMPEDANCES WERE DETECTED. THE AUTHORS REPORTEDLY COULD NOT RULE OUT THE MINIPLATE USED FOR LEAD FIXATION HAD CAUSED THE SHORT CIRCUIT. THE EVENT REPORTEDLY RESOLVED WITHOUT PERMANENT SEQUELAE. A PATIENT WITH STN-DBS UNDERWENT EXTENSION REPLACEMENT 66 MONTHS AFTER IMPLANT BECAUSE OF FRACTURE AFTER REPEATED FALLS. THE EVENT REPORTEDLY RESOLVED WITHOUT PERMANENT SEQUELAE. A PATIENT WITH STN-DBS UNDERWENT SUBMUSCULAR REPOSITIONING OF THE INS TO PREVENT ULCERATION 59 MONTHS AFTER IMPLANT. THE EVENT REPORTEDLY RESOLVED WITHOUT PERMANENT SEQUELAE. A PATIENT WITH STN-DBS UNDERWENT SUBMUSCULAR REPOSITIONING OF THE INS TO PREVENT ULCERATION 80 MONTHS AFTER IMPLANT. THE EVENT REPORTEDLY RESOLVED WITHOUT PERMANENT SEQUELAE. A PATIENT WITH STN-DBS EXPERIENCED DISCOMFORT AND REQUIRED REVISION BECAUSE OF CICATRICIAL TRACTION ALONG THE EXTENSION WIRE. THE EVENT REPORTEDLY RESOLVED WITHOUT PERMANENT SEQUELAE. A PATIENT WITH GPI-DBS EXPERIENCED REPOSITIONING OF A SLIPPED EXTENSION WIRE BEHIND THE INS TO PREVENT EROSION 7 MONTHS AFTER IMPLANT. THE EVENT REPORTEDLY RESOLVED WITHOUT PERMANENT SEQUELAE. A PATIENT WITH STN-DBS EXPERIENCED REPOSITIONING OF A SLIPPED EXTENSION WIRE BEHIND THE INS TO PREVENT EROSION 4 MONTHS AFTER IMPLANT. THE EVENT REPORTEDLY RESOLVED WITHOUT PERMANENT SEQUELAE. A PATIENT WITH GPI-DBS REQUIRED SURGICAL UNTWISTING OF THE EXTENSION WIRES AND REFIXATION OF THE INS 10 MONTHS AFTER IMPLANT. THE EVENT REPORTEDLY RESOLVED WITHOUT PERMANENT SEQUELAE. A PATIENT WITH A REPORTEDLY PROPERLY PLACED GPI-DBS LEAD UNDERWENT LEAD REPOSITIONING THAT DID NOT RESULT IN THERAPEUTIC EFFICACY. 11 PATIENTS FROM AMONG ALL PATIENTS IMPLANTED WITH DBS AT THE AUTHORS¿ INSTITUTION BETWEEN 2002 TO 2016 EXPERIENCED INFECTIONS. 6 PATIENTS FROM AMONG ALL PATIENTS IMPLANTED WITH DBS AT THE AUTHORS¿ INSTITUTION BETWEEN 2002 TO 2016 REQUIRED LEAD REVISIONS FOR UNSPECIFIED REASONS. THE AUTHORS NOTED THAT ALL ADVERSE EVENTS RELATED TO SURGERY AND THE IMPLANTED HARDWARE IN THIS COHORT WERE REVERSIBLE AND RESOLVED WITHOUT PERMANENT SEQUELAE. 9 PATIENTS FROM AMONG ALL PATIENTS IMPLANTED WITH DBS AT THE AUTHORS¿ INSTITUTION BETWEEN 2002 TO 2016 EXPERIENCED UNSPECIFIED INTRACRANIAL COMPLICATIONS. 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
    848186 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 Required Intervention