BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5660543 · Received May 17, 2016

    Report

    Report Number
    3007566237-2016-02009
    Event Type
    Injury
    Date Received
    May 17, 2016
    Date of Event
    September 12, 2002
    Report Date
    May 17, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387, PRODUCT TYPE: LEAD PRODUCT ID 3387, PRODUCT TYPE: LEAD. THE LITERATURE ARTICLES PROVIDED THE FOLLOWING SPECIFIC DEVICE INFORMATION: LEAD MODEL 3387, IMPLANTABLE NEUROSTIMULATOR KINETRA, IM PLANTABLE NEUROSTIMULATOR SYNERGY, AND IMPLANTABLE NEUROSTIMULATOR DUAL CHANNEL ITREL. 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

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

    Description of Event or Problem · 1

    YIANNI, J., BAIN, P., GILADI, N., AUCA, M., GREGORY, R., JOINT, C., NANDI, D., STEIN, J., SCOTT, R., AZIZ, T. GLOBUS PALLIDUS INTERNUS DEEP BRAIN STIMULATION FOR DYSTONIC CONDITIONS: A PROSPECTIVE AUDIT. MOVEMENT DISORDERS. 2003. 18: 4. SUMMARY: IN THE CURRENT ERA OF FUNCTIONAL SURGERY FOR MOVEMENT DISORDERS, DEEP BRAIN STIMULATION (DBS) OF THE GLOBUS PALLIDUS INTERNUS (GPI) IS EMERGING AS THE FAVOURED TARGET IN THE TREATMENT OF PATIENTS WITH DYSTONIA. THE RESULTS OF 25 CONSECUTIVE PATIENTS WITH MEDICALLY INTRACTABLE DYSTONIA (12 WITH GENERALISED DYSTONIA, 7 WITH SPASMODIC TORTICOLLIS, AND 6 WITH OTHER TYPES OF DYSTONIA) TREATED WITH GPI STIMULATION ARE REPORTED. ALTHOUGH COMPARISONS WERE LIMITED BY DIFFERENCES IN THEIR RESPECTIVE NEUROLOGICAL RATING SCALES, CHRONIC DBS BENEFITED ALL GROUPS, RESULTING IN CLEAR AND PROGRESSIVE IMPROVEMENTS IN THEIR CONDITION. THIS STUDY CLEARLY DEMONSTRATES THAT DBS OF THE GPI PROVIDES AMELIORATION OF INTRACTABLE DYSTONIA. REPORTED EVENTS: ONE (B)(6) FEMALE PATIENT WITH GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) FOR GENERALIZED DYSTONIA HAD A POSTOPERATIVE COURSE COMPLICATED BY THE LEFT DBS LEAD SLIPPING FROM ITS POSITION AS A RESULT OF A PLAYGROUND ACCIDENT SEVERAL MONTHS AFTER SURGERY. THIS MIGRATION GAVE RISE TO DETERIORATION IN NEUROLOGICAL FUNCTION. REPLACEMENT OF THE LEAD WAS FURTHER COMPLICATED BY INFECTION, NECESSITATING REMOVAL OF BOTH DEEP BRAIN STIMULATORS (THE ENTIRE SYSTEM). THIS REMOVAL RESULTED IN FURTHER ACUTE NEUROLOGICAL DETERIORATION (STATUS DYSTONICUS), REQUIRING ADMISSION TO THE INTENSIVE CARE UNIT FOR INTUBATION AND VENTILATION, AFTER DEVELOPMENT OF SEVERE SPASMODIC DYSPHONIA AND SPASMODIC LARYNGEAL DYSTONIA. GRADUAL SUSTAINED IMPROVEMENT IN HER CONDITION RECOMMENCED AFTER THE DBS LEADS WERE SUCCESSFULLY REPLACED FOR A SECOND TIME. RESOLUTION OF THE INFECTIVE PROCESS ALLOWED THE SUCCESSFUL REPLACEMENT OF BOTH ELECTRODES AND IMPLANTABLE NEUROSTIMULATOR, AFTER WHICH NEUROLOGICAL STATUS IMPROVED WITHIN HOURS. THIS WAS NOTED TO BE REBOUND PHENOMENON. THIS EVENT WAS REPORTED IN MULTIPLE LITERATURE ARTICLES;

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313812 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization| L| R