BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 9696341 · Received February 11, 2020

    Report

    Report Number
    6000030-2020-00020
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 1, 2020
    Report Date
    November 5, 2020
    Manufacturer
    RICE CREEK MFG
    Product Code
    MHY
    PMA / PMN Number
    960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    (B)(6). LONG VERSUS SHORT PULSE WIDTH SUBCALLOSAL CINGULATE STIMULATION FOR TREATMENT-RESISTANT DEPRESSION: A RANDOMISED, DOUBLE-BLIND, CROSSOVER TRIAL. LANCET PSYCHIATRY. 2020;7(1):29-40. 10.1016/S2215-0366(19)30415-8 A2: 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 PUBLICATION DATE AND 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. D2/PMA: SELECTED MFR AND H050003 AS THE PATIENTS IN THIS STUDY WERE IMPLANTED FOR A PSYCHIATRIC INDICATION. DEPRESSION IS AN OFF-LABEL INDICATION FOR USE.

    Description of Event or Problem · 1

    SUMMARY: STIMULATION ADJUSTMENT IS REQUIRED TO OPTIMIZE OUTCOMES OF DEEP BRAIN STIMULATION (DBS) FOR TREATMENT RESISTANT DEPRESSION, BUT CONTROLLED DATA FOR IDEAL STIMULATION PARAMETERS ARE POOR OR INSUFFICIENT. THE AUTHORS AIMED TO ESTABLISH THE EFFICACY AND SAFETY OF SHORT PULSE WIDTH (SPW) AND LONG PULSE WIDTH (LPW) SUBCALLOSAL CINGULATE DBS IN DEPRESSION. THE AUTHORS DID A DOUBLE-BLIND, RANDOMIZED, CROSSOVER TRIAL IN AN ACADEMIC HOSPITAL IN (B)(6). PATIENTS HAD DSM IV-DEFINED MAJOR DEPRESSIVE DISORDER AND BIPOLAR DEPRESSION ((20¿70 YEARS OLD, BOTH SEXES) AND DID NOT RESPOND TO TREATMENT FOR MORE THAN 1 YEAR, WITH A SCORE OF 20 OR MORE ON THE 17-ITEM HAMILTON DEPRESSION RATING SCALE (HDRS) AT RECRUITMENT. PATIENTS UNDERWENT BILATERAL DBS IMPLANTATION INTO THE SUBCALLOSAL CINGULATE WHITE MATTER USING DIFFUSION TENSOR IMAGING TRACTOGRAPHY. PATIENTS WERE RANDOMLY ASSIGNED 1:1 WITHOUT STRATIFICATION USING A COMPUTERIZED LIST GENERATOR TO RECEIVE EITHER SPW (90 ¿S) OR LPW (210¿450 ¿S) STIMULATION FOR 6 MONTHS. PATIENTS AND THE CLINICIAN ASSESSING OUTCOMES WERE MASKED TO THE STIMULATION GROUP. KEEPING FREQUENCY CONSTANT (130 HZ), EITHER PULSE WIDTH OR VOLTAGE WAS INCREASED MONTHLY, BASED ON RESPONSE USING THE HDRS. PATIENTS WHO DID NOT RESPOND TO TREATMENT (<(><<)>50% REDUCTION IN HDRS FROM BASELINE) AT 6 MONTHS CROSSED OVER TO THE OPPOSITE STIMULATION FOR ANOTHER 6 MONTHS. ALL PATIENTS RECEIVED INDIVIDUALIZED COGNITIVE BEHAVIORAL THERAPY (CBT) FOR 12 WEEKS. THE PRIMARY OUTCOME WAS CHANGE IN HDRS AT 6 MONTHS AND 12 MONTHS USING INTENTION-TO-TREAT ANALYSIS. BETWEEN DEC 5, 2013, AND SEPT 30, 2016, OF 225 PATIENTS SCREENED FOR ELIGIBILITY, 23 PATIENTS WERE SELECTED FOR DBS SURGERY. AFTER ONE PATIENT WITHDREW, 22 (MEAN AGE 46·4 YEARS, SEM 3·1; 10 [45%] FEMALE, 12 [55%] MALE) WERE RANDOMLY ASSIGNED, TEN (45%) TO LPW STIMULATION AND 12 (55%) TO SPW STIMULATION. PATIENTS WERE FOLLOWED UP AT 6 MONTHS AND 12 MONTHS. THERE WAS A SIGNIFICANT REDUCTION IN HDRS SCORES (P<(><<)>0·0001) WITH NO DIFFERENCE BETWEEN SPW AND LPW GROUPS (P=0·54) IN THE RANDOMIZATION PHASE AT 6 MONTHS. CROSSOV ER GROUPS DID NOT SHOW A SIGNIFICANT DECREASE IN HDRS WITHIN GROUPS (P=0·15) AND BETWEEN GROUPS (P=0·21) FROM 6¿12 MONTHS. ADVERSE EVENTS WERE EQUAL BETWEEN GROUPS. WORSENING ANXIETY AND DEPRESSION WERE THE MOST COMMON PSYCHOLOGICAL ADVERSE EVENTS. ONE PATIENT IN THE SPW GROUP DIED BY SUICIDE. INTERPRETATION BOTH LPW AND SPW STIMULATION OF SUBCALLOSAL CINGULATE WHITE MATTER TRACTS CARRIED SIMILAR RISKS AND WERE EQUALLY EFFECTIVE IN REDUCING DEPRESSIVE SYMPTOMS, SUGGESTING A ROLE FOR BOTH PULSE WIDTH AND AMPLITUDE TITRATION IN OPTIMIZING CLINICAL OUTCOMES IN PATIENTS WITH TREATMENT-RESISTANT DEPRESSION. REPORTED EVENTS: 1. TWO PATIENTS IMPLANTED WITH BILATERAL DEEP BRAIN STIMULATION (DBS) FOR TREATMENT RESISTANT DEPRESSION EXPERIENCED STINGING/BURNING AT INS SITE. THE FOLLOWING DEVICE SPECIFICS WERE IDENTIFIED IN THE LITERATURE ARTICLE: INS MODEL 37601 AND LEAD MODEL 3387.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156053 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY RICE CREEK MFG 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR