BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6889157 · Received September 23, 2017

    Report

    Report Number
    3007566237-2017-04025
    Event Type
    Injury
    Date Received
    September 23, 2017
    Date of Event
    July 5, 2017
    Report Date
    October 26, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    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. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. INFORMATION REFERENCES THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. 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):E0178984. DOI: 10.1371/JOURNAL.PONE.(B)(4).

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SENT TO REPORT ADDITIONAL INFORMATION REPORTED IN FOLLOW-UP ARTICLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: 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: A PATIENT EXPERIENCED LIFE-THREATENING PNEUMONIA/CONFUSION LESS THAN A MONTH AFTER IMPLANT THAT WAS ASSESSED AS DEFINITELY RELATED TO THE DEVICE/THERAPY, AND NECESSITATED INTENSIVE CARE UNIT (ICU) TREATMENT, WITHOUT INTUBATION. THE AUTHORS STATED THAT ALL SEVERE ADVERSE EVENTS THAT OCCURRED WITHIN THE FIRST MONTH OF SURGERY WERE REVERSIBLE. A PATIENT EXPERIENCED LIFE-THREATENING RESPIRATORY DISTRESS LESS THAN A MONTH AFTER IMPLANT THAT NECESSITATED POSTOPERATIVE NON-INVASIVE BREATHING ASSISTANCE (CPAP) IN THE ICU. THE EVENT WAS ASSESSED AS DEFINITELY RELATED TO THE DEVICE/THERAPY, BUT IT WAS ALSO NOTED THAT THE PATIENT HAD PREEXISTING CHRONIC OBSTRUCTIVE LUNG DISEASE. THE AUTHORS STATED THAT ALL SEVERE ADVERSE EVENTS THAT OCCURRED WITHIN THE FIRST MONTH OF SURGERY WERE REVERSIBLE. A PATIENT EXPERIENCED AN INTRACEREBRAL HEMORRHAGE ALONG WITH TRANSIENT COGNITIVE IMPAIRMENT THAT WAS ASSESSED AS DEFINITELY RELATED TO THE DEVICE/THERAPY. THERE WERE 21 REPORTED HARDWARE REVISIONS THAT WERE ASSESSED AS AT LEAST PROBABLY (20X DEFINITELY, 1X PROBABLY) RELATED TO THE DEVICE/THERAPY. NO DETAILS REGARDING THE CAUSE OF THESE REVISIONS WAS PROVIDED, BUT IT WAS STATED THAT NONE OF THE IMPLANTED LEADS HAD TO BE REVISED BECAUSE OF MISPLACEMENT, LACK OF EFFICACY OR INTOLERABLE SIDE-EFFECTS. THERE WAS 1 DEVICE EXPLANTATION THAT WAS ASSESSED AS DEFINITELY RELATED TO THE DEVICE/THERAPY. NO DETAILS REGARDING THE CAUSE OF EXPLANTATION WERE PROVIDED; 3 PATIENTS EXPERIENCED SEVERE ¿INJURIES¿ OF AN UNSPECIFIED VARIETY WITHIN 6 MONTHS OF IMPLANT THAT WERE ASSESSED BY THE AUTHORS AS A SEVERE ADVERSE EVENT PER FDA CRITERIA AND PROBABLY RELATED TO THE DEVICE/THERAPY. A PATIENT EXPERIENCED SEVERE CONFUSION LESS THAN A MONTH AFTER IMPLANT THAT WAS ASSESSED BY THE AUTHORS AS A SEVERE ADVERSE EVENT PER FDA CRITERIA AND AS PROBABLY RELATED TO THE DEVICE/THERAPY. THE AUTHORS STATED THAT ALL SEVERE ADVERSE EVENTS THAT OCCURRED WITHIN THE FIRST MONTH OF SURGERY WERE REVERSIBLE. A PATIENT EXPERIENCED A SEVERE ADVERSE EVENT RELATING TO GAIT 1-MONTH POST-IMPLANT THAT WAS ASSESSED BY THE AUTHORS AS A SEVERE ADVERSE EVENT PER FDA CRITERIA AND AS PROBABLY RELATED TO THE DEVICE/THERAPY; 2 PATIENTS EXPERIENCED A MODERATELY SEVERE ADVERSE EVENT RELATING TO GAIT 3 AND 16-MONTHS POST-IMPLANT THAT WERE ASSESSED BY THE AUTHORS AS A SEVERE ADVERSE EVENT PER FDA CRITERIA AND AS PROBABLY/POSSIBLY RELATED TO THE DEVICE/THERAPY. A PATIENT EXPERIENCED MODERATELY SEVERE CONFUSION 3-MONTHS AFTER IMPLANT THAT WAS ASSESSED BY THE AUTHORS AS A SEVERE ADVERSE EVENT PER FDA CRITERIA AND AS PROBABLY RELATED TO THE DEVICE/THERAPY. IT WAS NOTED THAT POSTOPERATIVE CONFUSION WAS REVERSIBLE IN ALL CASES. A PATIENT EXPERIENCED PROGRESSIVE COGNITIVE DISTURBANCES >2 YEARS POST- IMPLANT THAT WERE CONSIDERED POSSIBLY RELATED TO THE DBS BECAUSE THEY HAD ALREADY EXPERIENCED INITIALLY REVERSIBLE CONFUSION IN THE POSTOPERATIVE PERIOD. THE AUTHORS SUGGESTED THAT THIS PATIENT DEVELOPED DEMENTIA >2 YEARS POST-IMPLANT. 12. A PATIENT EXPERIENCED LOOSENING OF TEETH FOLLOWING INTUBATION. 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

    A PATIENT EXPERIENCED AN INTRACEREBRAL HEMORRHAGE ALONG WITH TRANSIENT COGNITIVE IMPAIRMENT THAT WAS ASSESSED AS DEFINITELY RELATED TO THE DEVICE/THERAPY. ADDITIONAL INFORMATION RECEIVED IN A FOLLOW-UP ARTICLE REPORTED THAT THE (B)(6) YEAR OLD PATIENT WITH SUBTHALAMIC NUCLEUS (STN) DBS EXPERIENCED A HEMORRHAGE ASSOCIATED WITH MODERATE AND REVERSIBLE COGNITIVE DEFICITS INCLUDING WORD FLUENCY AFTER IMPLANT. THESE SYMPTOMS IMPROVED SIGNIFICANTLY BEFORE DISCHARGE AND RESOLVED COMPLETELY WITHIN 3 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
    668864 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| O| R