BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7610470 · Received June 18, 2018

    Report

    Report Number
    3007566237-2018-01809
    Event Type
    Injury
    Date Received
    June 18, 2018
    Date of Event
    March 7, 2018
    Report Date
    June 18, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT. 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 MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. BARBOSA, B., CARRA, RB., DUARTE, KP., GODINHO, F., DE ANDRADE, DC., TEIXEIRA, MJ., BARBOSA, ER., CURY, RG. BILATERAL SUBTHALAMIC NUCLEUS STIMULATION IN REFRACTORY STATUS DYSTONICUS. J NEUROL SCI. 2018;388:159-161. DOI: 10.1016/J.JNS.2018.03.007. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: STATUS DYSTONICUS (SD) IS CHARACTERIZED BY GENERALIZED WORSENING, ALONG WITH A POTENTIALLY FATAL COMPLICATION OF ISOLATED OR COMBINED DYSTONIA. THIS RARE CONDITION IS USUALLY REFRACTORY TO CONVENTIONAL PHARMACOLOGICAL THERAPY, AND THERE IS NO CONSENSUS REGARDING OPTIMAL TREATMENT STRATEGY. IN RECENT YEARS, DEEP BRAIN STIMULATION (DBS) OF THE GLOBUS PALLIDUS PARS INTERNA (GPI) AND PALLIDOTOMY WERE USED TO TREAT DYSTONIA AND SD, BUT THE ROLE OF SUBTHALAMIC NUCLEUS (STN) STIMULATION ON SD HAS NEVER BEEN REPORTED. HERE WE ILLUSTRATE A CASE OF A REFRACTORY SD PATIENT, SUCCESSFULLY TREATED WITH STN-DBS, FOLLOWING TWO PALLIDUM-BASED TREATMENT STRATEGIES. REPORTED EVENTS: A (B)(6) BOY HAD A MEDICAL HISTORY OF SYMPTOMS OF DYT-1 DYSTONIA AT (B)(6) AND THEN DEVELOPED ACUTE WORSENING OF DYSTONIA SEVERE ENOUGH TO BE CLASSIFIED AS STATUS DYSTONICUS (SEVERE OPISTHOTONOS, HYPERKINETIC LIMB MOVEMENTS, AND RESPIRATORY FAILURE REQUIRING OROTRACHEAL INTUBATION AND INTRAVENOUS SEDATION), LATER UNDERWENT SUCCESSFUL PLANNED IMPLANTATION OF BILATERAL GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) LEADS AND WAS ABLE TO WALK WITHOUT AID WITHIN 4-WEEKS OF IMPLANT. HOWEVER, SIX WEEKS AFTER RETURNING HOME THE PATIENT DEVELOPED A FEVER WORSENING OF DYSTONIC MOVEMENTS, INFLAMMATORY SIGNS EXTENDING FROM THE IMPLANTABLE NEUROSTIMULATOR (INS) TO THE SCALP INCISIONS. BOTH LEADS WERE REPORTEDLY REMOVED DUE TO THIS INFECTION, AND THE PATIENT RELAPSED TO STATUS DYSTONICUS ON THE SAME DAY DESPITE OPTIMIZED SYSTEMIC PHARMACOLOGICAL TREATMENT. BILATERAL PALLIDOTOMY WAS ALSO PERFORMED WITH NO SIGNIFICANT IMPROVEMENT. ULTIMATELY, NEW LEADS TARGETING THE SUBTHALAMIC NUCLEUS (STN) WERE IMPLANTED LEADING TO SUSTAINED RELIEF OF DYSTONIC SYMPTOMS. 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
    452983 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening| R