BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 7744720 · Received August 2, 2018

    Report

    Report Number
    3007566237-2018-02296
    Event Type
    Injury
    Date Received
    August 2, 2018
    Date of Event
    May 1, 2018
    Report Date
    November 14, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ID 37601 LOT# UNKNOWN PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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. - ATTACHMENT: [LEOUTSAKOS_ANNUAL REPORT MARCH2018.PDF]

    Description of Event or Problem · 0

    1 PATIENTS WITH BILATERAL DEEP BRAIN STIMULATION OF THE FORNIX (DBS-F) FOR ALZHEIMER¿S DISEASE (AD) EXPERIENCED ¿NON-SERIOUS¿ INF ECTIOUS DISEASE RELATED ADVERSE EVENTS. ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR REPORTED THAT THEY HAD ONLY ONE NEW INFECTIOUS RELATED ADVERSE EVENT SINCE THE LAST ANNUAL UPDATE. FNM06006 EXPERIENCED SWELLING AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE THE DAY FOLLOWING A BATTERY REPLACEMENT. KEFLEX WAS REPORTEDLY ADDED OR DOSAGE CHANGED; 500 MG TWICE A DAY WAS PRESCRIBED, HOWEVER THE AUTHORS STATED THAT THE EVENT WAS NOT CONSIDERED A SERIOUS ADVERSE EVENT. 2. FNM04011 EXPERIENCED RAPID BATTERY DEPLETION AND THE DEVICE WAS REPLACED ON (B)(6) 2017. THE SUSPECTED CAUSE WAS THE INS. IN RESPONSE TO FOLLOW-UP THE CORRESPONDING AUTHOR PROVIDED THE FINAL ANNUAL PROGRESS REPORT FOR THE ADVANCE CLINICAL TRIAL TO THE FDA, WHICH INCLUDED MORE DETAILED TIMELINES AND DATES REGARDING ALL ADVERSE EVENTS COLLECTED DURING THE ENTIRE STUDY PERIOD. SEE THE FDA ANNUAL REPORT ATTACHED.

    Additional Manufacturer Narrative · 1

    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; LEOUTSAKOS, JS., YAN, H., ANDERSON, WS., ASAAD, WF., BALTUCH, G., BURKE, A., CHAKRAVARTY, MM., DRAKE, KE., FOOTE, KD., FOSDICK, L., GIACOBBE, P., MARI, Z., MCANDREWS, P., MUNRO, CA., OH, ES., OKUN, MS., PENDERGRASS, JC., PONCE, FA., ROSENBERG, PB., SABBAGH, MN., SALLOWAY, S., TANG-WAI, DF., TARGUM, SD., WOLK, D., LOZANO, AM., SMITH, GS., LYKETSOS, CG. DEEP BRAIN STIMULATION TARGETING THE FORNIX FOR MILD ALZHEIMER DEMENTIA (THE ADVANCE TRIAL): A TWO YEAR FOLLOW-UP INCLUDING RESULTS OF DELAYED ACTIVATION. J ALZHEIMER¿S DIS. 2018;64(2):597-606. DOI: 10.3233/JAD-180121. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: GIVEN RECENT CHALLENGES IN DEVELOPING NEW TREATMENTS FOR ALZHEIMER DEMENTIA (AD), IT IS VITAL TO EXPLORE ALTERNATE TREATMENT TARGETS, SUCH AS NEUROMODULATION FOR CIRCUIT DYSFUNCTION. WE PREVIOUSLY REPORTED AN EXPLORATORY PHASE IIB DOUBLE-BLIND TRIAL OF DEEP BRAIN STIMULATION TARGETING THE FORNIX (DBS-F) IN MILD AD (THE ADVANCE TRIAL). WE REPORTED SAFETY BUT NO CLINICAL BENEFITS OF DBS-F VERSUS THE DELAYED-ON (SHAM) TREATMENT IN 42 PARTICIPANTS AFTER ONE YEAR. HOWEVER, SECONDARY POST HOC ANALYSES OF THE ONE-YEAR DATA SUGGESTED A POSSIBLE DBS-F BENEFIT FOR PARTICIPANTS=65 YEARS. OBJECTIVE: TO EXAMINE THE LONG-TERM SAFETY AND CLINICAL EFFECTS OF SUSTAINED AND DELAYED-ON DBS-F TREATMENT OF MILD AD AFTER TWO YEARS. METHODS: 42 PARTICIPANTS UNDERWENT IMPLANTATION OF DBS-F ELECTRODES, WITH HALF RANDOMIZED TO ACTIVE DBS-F STIMULATION (EARLY ON) FOR TWO YEARS AND HALF TO DELAYED-ON (SHAM) STIMULATION AFTER 1 YEAR TO PROVIDE 1 YEAR OF ACTIVE DBS-F STIMULATION (DELAYED ON). WE EVALUATED SAFETY AND CLINICAL OUTCOMES OVER THE TWO YEARS OF THE TRIAL. RESULTS: DBS-F HAD A FAVORABLE SAFETY PROFILE WITH SIMILAR RATES OF ADVERSE EVENTS ACROSS BOTH TRIAL PHASES (YEARS 1 AND 2) AND BETWEEN TREATMENT ARMS. THERE WERE NO DIFFERENCES BETWEEN TREATMENT ARMS ON ANY PRIMARY CLINICAL OUTCOMES. HOWEVER, POST-HOC AGE GROUP ANALYSES SUGGESTED A POSSIBLE BENEFIT AMONG OLDER (>65) PARTICIPANTS. CONCLUSION: DBS-F WAS SAFE. ADDITIONAL STUDY OF MECHANISMS OF ACTION AND METHODS FOR TITRATING STIMULATION PARAMETERS WILL BE NEEDED TO DETERMINE IF DBS HAS POTENTIAL AS AN AD TREATMENT. FUTURE EFFICACY STUDIES SHOULD FOCUS ON PATIENTS OVER AGE 65. REPORTED EVENTS: 1 PATIENTS WITH BILATERAL DEEP BRAIN STIMULATION OF THE FORNIX (DBS-F) FOR ALZHEIMER¿S DISEASE (AD) EXPERIENCED ¿NON-SERIOUS¿ INFECTIOUS DISEASE RELATED ADVERSE EVENTS. ALL PATIENTS WERE IMPLANTED WITH 37601 ACTIVA PCS AND 3387 MODEL LEADS. IT WAS NOT POSSIBLE TO ASCERTAIN 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
    586539 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37601 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other