BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 9589477 · Received January 14, 2020

    Report

    Report Number
    3007566237-2020-00080
    Event Type
    Injury
    Date Received
    January 14, 2020
    Date of Event
    November 11, 2019
    Report Date
    November 5, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G5(PMA): UPDATED TO H050003 WHICH IS FOR PSYCHIATRIC INDICATIONS. 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.

    Additional Manufacturer Narrative · 0

    D2/G5: PLEASE NOTE THAT THIS DEVICE WAS USED IN AN OFF-LABEL MANNER AS IT WAS IMPLANTED FOR DEPRESSION. 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.

    Additional Manufacturer Narrative · 1

    VAN DER WAL, J.M., BERGFELD, I.O., LOK, A., MANTIONE, M., FIGEE, M., NOTTEN, P., BEUTE, G., HORST, F., VAN DEN MUCKHOF, P., SCHUURMAN, P.R., DENYS, D. "LONG-TERM DEEP BRAIN STIMULATION OF THE VENTRAL ANTERIOR LIMB OF THE INTERNAL CAPSULE FOR TREATMENT-RESISTANT DEPRESSION". JOURNAL OF NEUROLOGY, NEUROSURGERY AND PSYCHIATRY. 2019. DOI: 10.1136/JNNP-2019-321758. 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 THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, IMPLANTED: UNKNOWN, EXPLANTED: UNKNOWN, UBD: ASKU, UDI#: (B)(4), PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, IMPLANTED: UNKNOWN, EXPLANTED: UNKNOWN, UBD: ASKU, UDI#: (B)(4). (PMA): DEPRESSION IS NOT AN APPROVED ON-LABEL THERAPY INDICATION FOR EITHER ACTIVA PC 37601 OR ACTIVA RC 37612 (THE TWO MODELS USED IN THIS STUDY). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: DEEP BRAIN STIMULATION (DBS) REDUCES DEPRESSIVE SYMPTOMS IN APPROXIMATELY 40%¿60% OF PATIENTS WITH TREATMENT-RESISTANT DEPRESSION (T RD), BUT DATA ON LONG-TERM EFFICACY AND SAFETY ARE SCARCE. THE OBJECTIVE WAS TO ASSESS THE EFFICACY AND SAFETY OF DBS TARGETED AT THE VENTRAL ANTERIOR LIMB OF THE INTERNAL CAPSULE (VALIC) IN 25 PATIENTS WITH TRD DURING A 1-YEAR, OPEN-LABEL, MAINTENANCE PERIOD, WHICH FOLLOWED A 1-YEAR OPTIMIZATION PERIOD. DEPRESSION SEVERITY WAS MEASURED USING THE 17-ITEM HAMILTON DEPRESSION RATING SCALE (HAM-D-17), MONTGOMERY-ASBERG DEPRESSION RATING SCALE (MADRS) AND SELF-REPORTED INVENTORY OF DEPRESSIVE SYMPTOMATOLOGY (IDS-SR). PRIMARY OUTCOMES WERE RESPONSE RATE (=50% HAM-D-17 SCORE REDUCTION) AFTER THE MAINTENANCE PHASE, APPROXIMATELY 2 YEARS AFTER DBS SURGERY, AND CHANGES IN DEPRESSION SCORES AND OCCURRENCE OF ADVERSE EVENTS DURING THE MAINTENANCE PHASE. OF 25 OPERATED PATIENTS, 21 ENTERED AND 18 COMPLETED THE MAINTENANCE PHASE. AFTER THE MAINTENANCE PHASE, EIGHT PATIENTS WERE CLASSIFIED AS RESPONDER (OBSERVED RESPONSE RATE: 44.4%; INTENTION-TO- TREAT: 32.0%). DURING THE MAINTENANCE PHASE, HAM-D-17 AND MADRS SCORES DID NOT CHANGE, BUT THE MEAN IDS-SR SCORE DECREASED FROM 38.8 (95% CI 31.2 TO 46.5) TO 35.0 (95% CI 26.1 TO 43.8) (P=0.008). NON-RESPONDERS AFTER OPTIMIZATION DID NOT IM PROVE DURING THE MAINTENANCE PHASE. FOUR NON-DBS-RELATED SERIOUS ADVERSE EVENTS OCCURRED, INCLUDING ONE SUICIDE ATTEMPT. VALIC DBS FOR TRD SHOWED CONTINUED EFFICACY 2 YEARS AFTER SURGERY, WITH SYMPTOMS REMAINING STABLE AFTER OPTIMIZATION AS RATED BY CLINICIANS AND WITH PATIENT RATINGS IMPROVING. THIS SUPPORTS DBS AS A VIABLE TREATMENT OPTION FOR PATIENTS WITH TRD. REPORTED EVENTS: 1. SIX PATIENTS IMPLANTED WITH VENTRAL ANTERIOR LIMB OF THE INTERNAL CAPSULE DEEP BRAIN STIMULATION (VALIC-DBS) FOR TREATMENT-RESISTANT DEPRESSION (TRD) EXPERIENCED SEVEN INSTANCES OF TRANSIENT, SUICIDAL IDEATION. 2. ONE PATIENT IMPLANTED WITH VALIC-DBS FOR TRD EXPERIENCED TWO INSTANCES OF TRANSIENT INCREASE IN DEPRESSIVE THOUGHTS, WHICH WAS DE SCRIBED AS A SERIOUS ADVERSE EVENT PER THE AUTHOR'S DEFINITION, "RESULTED IN DEATH, LIFE-THREATENING SITUATIONS, (PROLONGED) HOSPITALIZATION OR CHRONIC DISABILITY." THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) DEPLETED WHICH RESULTED IN RELAPSE OF DEPRESSIVE SYMPTOMS AND AN INCREASE IN DEPRESSIVE SYMPTOMS/SUICIDAL IDEATIONS. IT TOOK SEVERAL MONTHS (27 MONTHS) AFTER BATTERY REPLACEMENT TO REGAIN FULL RESPONSE. THE PATIENT WAS CLASSIFIED AS A STRONG IMPROVER AT BOTH T2 AND T5. 3. ONE PATIENT IMPLANTED WITH VALIC-DBS FOR TRD EXPERIENCED TRANSIENT AUTO-MUTILATION, WHICH WAS NOT CLASSIFIED AS A SERIOUS ADVERSE EVENT PER THE STUDY DEFINITION: "RESULTED IN DEATH, LIFE-THREATENING SITUATIONS, (PROLONGED) HOSPITALIZATION OR CHRONIC DISABILITY." THE FOLLOWING DEVICE INFORMATION WAS IDENTIFIED IN THE LITERATURE ARTICLE: INS MODELS 37612 AND 37601, LEAD MODEL 3389.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50944 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| O "SEE H10...."