BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 9834799 · Received March 16, 2020

    Report

    Report Number
    6000030-2020-00142
    Event Type
    Injury
    Date Received
    March 16, 2020
    Report Date
    March 16, 2020
    Manufacturer
    RICE CREEK MFG
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    HAMED M, BA F, SUCHOWERSKY O, SANKAR T. DEPLETING IMPLANTED PULSE GENERATOR (IPG) BATTERY VOLTAGE IS ASSOCIATED WITH WORSENING CLINICAL SYMPTOMS IN MOVEMENT DISORDER PATIENTS RECEIVING DEEP BRAIN STIMULATION (DBS). CLINICAL PARKINSONISM & RELATED DISORDERS. 2019;1:98-99. 10.1016/J.PRDOA.2019.11.001 SUMMARY: DEEP BRAIN STIMULATION (DBS) RESULTS IN SUPERIORMOTOR SYMPTOMCONTROL COMPARED TO MEDICAL TREATMENT ALONE IN PROPERLY SELECTED PATIENTS WITH ESSENTIAL TREMOR (ET), DYSTONIA (DYT), AND PARKINSON'S DISEASE (PD) [1]. OVER TIME, THE BATTERY LIFE OF A DBS SYSTEM'S IMPLANTABLE PULSE GENERATOR (IPG) BECOMES DRAINED, NECESSITATING REPLACEMENT [2]. WORSENING OF MOTOR SYMPTOMS ACCOMPANYING DEPLETED IPG BATTERY LIFE HAS BEEN REPORTED WITH EARLIER MEDTRONIC KINETRA AND SOLETRA MODELS OF IPGS [2,3]. HOWEVER, CURRENT GENERATION ACTIVA SC AND PC MODELS, WHICH HAVE BEEN DESIGNED WITH ELECTIVE REPLACEMENT INDICATORS (ERI) TO WARN PATIENTS OF IMPENDING IPG BATTERY FAILURE OR END-OF-SERVICE (EOS), HAVE RECEIVED LESS SCRUTINY. IDENTIFIED EVENTS: 4 PATIENTS UNDERWENT INS REPLACEMENT DUE TO PATIENT-REPORTED WORSENING OF SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300849 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY RICE CREEK MFG NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention