BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 9794548 · Received March 5, 2020

    Report

    Report Number
    3007566237-2020-00306
    Event Type
    Injury
    Date Received
    March 5, 2020
    Date of Event
    January 8, 2020
    Report Date
    March 5, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. CORRIPIO I, ROLDAN A, SARRO S, ET AL. DEEP BRAIN STIMULATION IN TREATMENT RESISTANT SCHIZOPHRENIA: A PILOT RANDOMIZED CROSS-OVER CLINICAL TRIAL. EBIOMEDICINE. 2020;51:102568. 10.1016/J.EBIOM.2019.11.029. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    EIGHT PATIENTS WITH SCHIZOPHRENIA, WHO MET CRITERIA FOR TREATMENT RESISTANCE AND WERE ALSO RESISTANT TO/INTOLERANT OF CLOZAPINE, WERE RANDOMLY ASSIGNED USING CENTRAL ALLOCATION TO RECEIVE DBS IN THE NACC OR SUBGENUAL ACC. AN OPEN STABILIZATION PHASE LASTING AT LEAST SIX MONTHS WAS FOLLOWED BY A RANDOMIZED DOUBLE BLIND CROSSOVER PHASE LASTING 24 WEEKS IN THOSE WHO MET SYMPTOMATIC IMPROVEMENT CRITERIA. THE PRIMARY END-POINT WAS A 25% IMPROVEMENT IN PANSS TOTAL SCORE. REPORTED EVENTS: ONE PATIENT HAD FULL REMISSION OF SYMPTOMS APART FROM INTERMITTENT RECURRENCES OF POSITIVE SYMPTOMS, WHICH EXCLUSIVELY TOOK THE FORM OF DELUSIONS AND HALLUCINATIONS. THIS REQUIRED FREQUENT ALTERATIONS OF STIMULATION SETTINGS. THIS PATIENT ALSO DEVELOPED HYPOMANIA IMMEDIATELY AFTER STOPPING ANTIPSYCHOTIC MEDICATIONS. THE PATIENT WAS AT ADMITTED IN A MIXED AFFECTIVE STATE WHICH RESPONDED TO ANTIPSYCHOTICS. SINCE THEN THE PATIENT'S CLINICAL STATE WAS CONSIDERED MOOD INSTABILITY WITH FLUCTUATIONS OF IMPULSIVE BEHAVIOR AND AT TIMES SUICIDAL IDEATIONS. THESE SYMPTOMS OFTEN CORRELATE WITH TIMES OF HIGH STRESS. AT ONE POINT, THIS PATIENT WAS SYMPTOM FREE FOR 10 MONTHS WHEN THEIR STIMULATION WAS TURNED OFF UNKNOWN TO THE PATIENT AND INVESTIGATORS. IT WAS UNCLEAR WHAT HAPPENED, BUT THE INVESTIGATORS SPECULATED THAT EITHER A BUTTON WAS PRESSED ON ACCIDENT DURING A CLINIC VISIT OR THE STIMULATOR WAS INTERRUPTED WHEN THEY PASSED THROUGH A SECURITY SCANNER AT A TOURIST ATTRACTION. THE PATIENT'S SYMPTOMS RETURNED WITHIN 24 HOURS AND REMAINED UNTIL IT WAS DETERMINED THAT THE INS WAS OFF A FEW DAYS LATER. THE INS WAS TURNED BACK ON AND THE SYMPTOMS IMPROVED 20 MINUTES LATER. CORRIPIO I, ROLDAN A, SARRO S, ET AL. DEEP BRAIN STIMULATION IN TREATMENT RESISTANT SCHIZOPHRENIA: A PILOT RANDOMIZED CROSS-OVER CLINICAL TRIAL. EBIOMEDICINE. 2020;51:102568. 10.1016/J.EBIOM.2019.11.029.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257833 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening| O