BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6889162 · Received September 23, 2017

    Report

    Report Number
    3007566237-2017-04026
    Event Type
    Injury
    Date Received
    September 23, 2017
    Date of Event
    July 5, 2017
    Report Date
    October 26, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    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. INFORMATION REFERENCES THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN. BUHMANN, C., HUCKHAGEL, T., ENGEL, K., GULBERTI, A., HIDDING, U., POETTER-NERGER, M., GOERENDT, I., LUDEWIG, P., BRAASS, H., CHOE, C., KRAJEWSKI, K., OEHLWEIN, C., MITTMANN, K., ENGEL, AK., GERLOFF, C., WESTPHAL, M., KÖPPEN, JA., MOLL, CKE., HAMEL, W. ADVERSE EVENTS IN DEEP BRAIN STIMULATION: A RETROSPECTIVE LONG-TERM ANALYSIS OF NEUROLOGICAL, PSYCHIATRIC AND OTHER OCCURRENCES. PLOS ONE. 2017;12(7):(B)(4). DOI:.(B)(4). 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. (B)(4).

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SENT FOR ADDITIONAL INFORMATION RECEIVED IN A FOLLOW-UP PUBLICATION. CODES UPDATED BASED ON NEW CURRENT PROCEDURES AND FOLLOW-UP INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW DETERMINED (B)(4) APPLIED TO THE EVENT. SUPPLEMENTAL SENT TO INDICATE THIS UPDATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE EXTENT TO WHICH DEEP BRAIN STIMULATION (DBS) CAN IMPROVE QUALITY OF LIFE MAY BE PERCEIVED AS A PERMANENT TRADE-OFF BETWEEN NEUROLOGICAL IMPROVEMENTS AND COMPLICATIONS OF THERAPY, COMORBIDITIES, AND DISEASE PROGRESSION. PATIENTS AND METHODS WE RETROSPECTIVELY INVESTIGATED 123 CONSECUTIVE AND NON-PRESELECTED PATIENTS. INDICATIONS FOR DBS SURGERY WERE PARKINSON'S DISEASE (82), DYSTONIA (18), TREMOR OF DIFFERENT ETIOLOGY (21), HUNTINGTON'S DISEASE (1) AND GILLES DE LA TOURETTE SYNDROME (1). AES WERE DEFINED AS ANY UNTOWARD CLINICAL OCCURRENCE, SIGN OR PATIENT COMPLAINT OR UNINTENDED DISEASE IF RELATED OR UNRELATED TO THE SURGICAL PROCEDURES, IMPLANTED DEVICES OR ONGOING DBS THERAPY. RESULTS OVER A MEAN/MEDIAN FOLLOW-UP PERIOD OF 4.7 YEARS (578 PATIENT-YEARS) 433 AES WERE RECORDED IN 106 OF 123 PATIENTS (86.2%). THERE WAS NO MORTALITY OR PERSISTENT MORBIDITY FROM THE SURGICAL PROCEDURE. ALL SERIOUS ADVERSE EVENTS (SAES) THAT OCCURRED WITHIN 4 WEEKS OF SURGERY WERE REVERSIBLE. NEUROLOGICAL AES (193 IN 85 PATIENTS) AND PSYCHIATRIC AES (78 IN 48 PATIENTS) WERE DOCUMENTED MOST FREQUENTLY. AES IN 4 PATIENTS (SUICIDE UNDER GPI STIMULATION, WEIGHT GAIN >20 KG, IMPAIRMENT OF GAIT AND SPEECH, COGNITIVE DECLINE >2 YEARS FOLLOWING SURGERY) WERE SEVERE OR WORSE, AT LEAST POSSIBLY RELATED TO DBS AND NON REVERSIBLE. IN PD 23.1% OF THE STN-STIMULATED PATIENTS EXPERIENCED NON-REVERSIBLE (OR UNKNOWN REVERSIBILITY) AES THAT WERE AT LEAST POSSIBLY RELATED TO DBS IN THE FORM OF IMPAIRED SPEECH OR GAIT, DEPRESSION, WEIGHT GAIN, COGNITIVE DISTURBANCES OR URINARY INCONTINENCE (SEVERITY WAS MILD OR MODERATE IN 15 OF 18 PATIENTS). AGE AND HOEHN & YAHR STAGE OF STN-SIMULATED PD PATIENTS, BUT NOT PREOPERATIVE MOTOR IMPAIRMENT OR RESPONSE TO LEVODOPA, SHOWED A WEAK CORRELATION (R = 0.24 AND 0.22, RESPECTIVELY) WITH THE NUMBER OF AES. CONCLUSIONS DBS-RELATED AES THAT WERE SEVERE OR WORSE AND NON-REVERSIBLE WERE ONLY OBSERVED IN PD (4 OF 82 PATIENTS; 4.9%), BUT NOT IN OTHER DISEASES. PD PATIENTS EXHIBITED A SIGNIFICANT RISK FOR NON-SEVERE AES MOST OF WHICH ALSO REPRESENTED PREEXISTING AND PROGRESSIVE AXIAL AND NONMOTOR SYMPTOMS OF PD. MILD GAIT AND/OR SPEECH DISTURBANCES WERE RATHER FREQUENT COMPLAINTS UNDER VIM STIMULATION. GPI STIMULATION FOR DYSTONIA COULD BE APPLIED WITH NEGLIGIBLE DBS-RELATED SIDE EFFECTS. REPORTED EVENTS: 1. A PATIENT WITH DBS FOR DYSTONIA EXPERIENCED TRANSIENT PARESIS LESS THAN A MONTH AFTER IMPLANT THAT WAS ASSESSED AS DEFINITELY RELATED TO THE DEVICE/THERAPY. THEY STATED THAT INITIATION OF MOVEMENTS WAS DISTURBED BY INTRACEREBRAL HEMORRHAGE IN THIS PATIENT, BUT FULL INNERVATION NORMAL MUSCLE STRENGTH COULD BE ACHIEVED. THE AUTHORS STATED THAT THE EVENT RESOLVED COMPLETELY WITHIN THE WEEKS FOLLOWING. 2. A PATIENT WITH DBS FOR DYSTONIA EXPERIENCED REVERSIBLE HALLUCINATION. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Description of Event or Problem · 1

    REPORTED EVENTS: A PATIENT WITH DBS FOR DYSTONIA EXPERIENCED TRANSIENT PARESIS LESS THAN A MONTH AFTER IMPLANT THAT WAS ASSESSED AS DEFINITELY RELATED TO THE DEVICE/THERAPY. THEY STATED THAT INITIATION OF MOVEMENTS WAS DISTURBED BY INTRACEREBRAL HEMORRHAGE IN THIS PATIENT, BUT FULL INNERVATION NORMAL MUSCLE STRENGTH COULD BE ACHIEVED. THE AUTHORS STATED THAT THE EVENT RESOLVED COMPLETELY WITHIN THE WEEKS FOLLOWING. ADDITIONAL INFORMATION REPORTED FROM IN A FOLLOW-UP PUBLICATION REPORTED THAT THE (B)(6) OLD PATIENT HAD GLOBUS PALLIDUS INTERNUS (GPI) AND EXPERIENCED A HEMORRHAGE ASSOCIATED WITH MODERATE AND REVERSIBLE COGNITIVE DEFICITS, DYSPHASIA, GAIT DISTURBANCES WITH DELAYED MOBILIZATION AND PROBLEMS WITH MOVEMENT INITIATION (BUT NORMAL STRENGTH AFTER FULL INNERVATION) CONTRALATERAL TO THE HEMATOMA. SYMPTOMS IMPROVED DURING THE HOSPITAL STAY AND FULLY RESOLVED WITHIN THREE MONTHS. THE PATIENT REPORTEDLY HAD A HISTORY OF CORONARY ARTERY DISEASE WHICH REQUIRED STENTING AND HAD DISCONTINUED ASPIRIN ONE WEEK PRIOR TO THE IMPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668862 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other