BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 14161302 · Received April 20, 2022

    Report

    Report Number
    2182207-2022-00669
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    February 22, 2022
    Report Date
    August 17, 2023
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    OLM
    PMA / PMN Number
    H050003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_INS_STIMULATOR , SERIAL# UNKNOWN , PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR ; OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. PARVARESH-RIZI, M., GHADIRIVASFI, M., BABAEI, S., BAGHER SABERI ZAFARGHANDI, M., FATTAHI, A., AMIRHASAN HABIBI, S., ROHANI, M., AREZ OOMANDAN, R. PSYCHOPATHOLOGICAL AND NEUROPSYCHOLOGICAL OUTCOMES OF DEEP BRAIN STIMULATION FOR SEVERE- TREATMENT-RESISTANT OBSESSIVE-COMPULSIVE DISORDER: AN OPEN-LABEL CASE SERIES. JOURNAL OF CLINICAL NEUROSCIENCE 98 (2022). DOI.ORG/10.1016/J.JOCN.2022.02.015. AGE OR DATE OF BIRTH: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. EVENT: 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    PRODUCT ID 37601 LOT# SERIAL# UNKNOWN IMPLANTED: (B)(6) 2019 PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR WEIGHT PROVIDED IS AN ESTIMATE OF THE PATIENT'S OVERALL WEIGHTS. IMPLANT DATE PROVIDED WAS THE YEAR 2019. EXACT DATE IS UNKNOWN. 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.

    Description of Event or Problem · 0

    PARVARESH-RIZI, M., GHADIRIVASFI, M., BABAEI, S., BAGHER SABERI ZAFARGHANDI, M., FATTAHI, A., AMIRHASAN HABIBI, S., ROHANI, M., AREZ OOMANDAN, R. PSYCHOPATHOLOGICAL AND NEUROPSYCHOLOGICAL OUTCOMES OF DEEP BRAIN STIMULATION FOR SEVERE- TREATMENT-RESISTANT OBSESSIVE-COMPULSIVE DISORDER: AN OPEN-LABEL CASE SERIES. JOURNAL OF CLINICAL NEUROSCIENCE 98 (2022). DOI.ORG/10.1016/J.JOCN.2022.02.015. SUMMARY: OBJECTIVE: DEEP BRAIN STIMULATION (DBS) IS CONSIDERED A PROMISING INTERVENTION FOR TREATMENT-RESISTANT OBSESSIVE¿COMPULSIVE DISORDER (OCD). THE PRESENT STUDY DESCRIBES THE OUTCOMES OF THE FIRST DBS PROCEDURES FOR OCD IN IRAN. METHODS: FOUR WOMEN PATIENTS (AGE RANGE, 25¿35 YEARS) WITH SEVERE OCD MEETING STRINGENT CRITERIA FOR REFRACTORINESS TO TREATMENT WERE SELECTED BY PSYCHOSURGERY REVIEW BOARD. DBS ELECTRODES WERE BILATERALLY IMPLANTED IN THE INTERNAL CAPSULE AND NUCLEUS ACCUMBENS (NAC). CLINICAL AND NEUROPSYCHOLOGICAL ASSESSMENTS WERE UNDERTAKEN BEFORE AND AFTER IMPLANTATION. THE OUTCOMES INCLUDED YALE-BROWN OBSESSIVE-COMPULSIVE SCALE (Y-BOCS) HAMILTON ANXIETY RATING SCALE (HAM-A), NEUROPSYCHOLOGICAL ASSESSMENTS INCLUDING THE WISCONSIN CARD SORTING TEST, WECHSLER MEMORY SCALE, AND ADVERSE EVENTS. RESULTS: THE BASELINE MEAN SCORE OF THE Y-BOCS AND HAM-A WAS 32 ± 6 AND 23 ± 14 RESPECTIVELY AND DECREASED TO 26 ± 8 AND 17 ± 9 AFTER ONE-YEAR IMPLANTATION, SHOWING A 19% IMPROVEMENT. TWO PATIENTS WERE RESPONDERS AND SHOWED A NOTABLE IMPROVEMENT. ONE PATIENT¿S SCORE DECLINED 28%, WHO WAS NOT SATISFIED WITH DBS RESULTS, AND ONE PATIENT WORSENED UNDER STIMULATION. IMPROVEMENTS IN THE SEVERITY OF ANXIETY AND COGNITIVE PERFORMANCE WERE CONSISTENT WITH OCD IMPROVEMENT, AND THE SUCCESSFULLY TREATED PATIENTS SHOWED IMPROVEMENT IN ANXIETY AND COGNITIVE PERFORMANCE. NO SIGNIFICANT COGNITIVE DECLINES WERE SEEN. TWO PATIENTS¿ SUICIDAL IDEATION APPEARED AFTER DBS AS AN IMPORTANT ADVERSE EVENT. CONCLUSION: BILATERAL DBS OF THE INTERNAL CAPSULE/NAC MAY BE AN EFFECTIVE AND SAFE TREATMENT FOR TREATMENTREFRACTORY OCD. HOWEVER, THERE IS A NEED TO CONSIDER ACCESSIBILITY, HIGH COST, COST-EFFECTIVENESS, AND STANDARDIZED METHODOLOGY IN FUTURE RESEARCH. REPORTED EVENTS: IT WAS REPORTED THAT AFTER DBS AND OPTIMIZATION, PATIENT 3'S CONDITION DID NOT IMPROVE IN POSTOPERATIVE EVALUATIONS. THE PATIENT'S CONDITION WORSENED AFTER THE SURGERY. AFTER A YEAR, THE INDIVIDUALS CONDITION DID NOT IMPROVE FOR ANXIETY, SHOWING WORSENING OCD CONDITIONS. ACCORDING TO THE PATIENT'S FAMILY, HER OCD SYMPTOMS, ANXIETY, AND DEPRESSION WORSENED AFTER A WHILE. AFTER A YEAR OF IMPLANTATION, SHE HAD SUICIDAL THOUGHTS BUT DID NOT ATTEMPT TO DO IT. SHE WAS SPENDING A LONG TIME IN THE BATHROOM. THE BATTERY WAS ON FOR UP TO 10 MONTHS AFTER THE OPERATION. BECAUSE THE PATIENT'S EXPECTATIONS WERE NOT MET, THE BATTERY WAS COMPLETELY TURNED OFF, AND HER CONDITION DETERIORATED. THERE WAS NO ATTEMPT TO TURN IT ON AGAIN. THEY FOUND NO IMPROVEMENT IN COGNITIVE PERFORMANCE, AND HER PERFORMANCE WORSENED IN SOME SUBSCALES. IT WAS REPORTED THAT PATIENT 4 AND HER FAMILY WERE DISSATISFIED WITH THE TREATMENT PROCESS, AND THEY REPORTED THAT ALL SYMPTOMS APPEARED EVEN MORE SEVERELY COMPARED TO THE PRE-OPERATION CONDITION. AFTER 8 MONTHS OF IMPLANTATION, ANXIETY AND DEPRESSION SYMPTOMS WITH SUICIDAL IDEATION INTENSIFIED, AND THEY WERE VERY DISSATISFIED WITH THE SURGERY AND WAS DISAPPOINTED WITH THE CONSEQUENCES. AFTER 7 MONTHS OF IMPLANTATION, THE BATTERY DRAINED, AND DUE TO NO IMPROVEMENTS IN SYMPTOMS, NO ATTEMPT WAS MADE TO REPLACE IT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT'S RECEIVED DEVISE OPTIMIZATION AND PSYCHIATRIC DRUGS (BASED ON THEIR SYMPTOMS AND SEVERITY) AND PSYCHOLOGICAL INTERVENTIONS AFTER SURGERY. SOME SYMPTOMS DID RESOLVE AND THE INDIVIDUALS CONDITION DID NOT IMPROVE, THEREFORE THEY DID NOT COME TO THE CENTER FOR FOLLOW-UP FOR RECEIVING PHARMACOLOGICAL/NON-PHARMACOLOGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2648982 ACTIVA DEEP BRAIN STIMULATOR FOR OBSESSIVE COMPULSIVE DISORDER (OCD) OLM MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Other