BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5660437 · Received May 17, 2016

    Report

    Report Number
    3007566237-2016-02008
    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 THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387, PRODUCT TYPE: LEAD. THE ARTICLES STATED THE FOLLOWING DEVICE SPECIFICS: LEAD MODEL 3387, IMPLANTABLE NEUROSTIMULATOR KINETRA, IMPLANTABLE 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: TWO PATIENTS WITH GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) FOR DYSTONIA EXPERIENCED A REBOUND PHENOMENON, ONE OF WHOM HAD A DAMAGED LEAD CONNECTOR, WHILST IN THE OTHER PATIENT THE PULSE GENERATOR BATTERY HAD RUN OUT SUDDENLY. THIS LED TO A POTENTIALLY LIFE-THREATENING RELAPSE OF THEIR DYSTONIA (STATUS DYSTONICUS). THE PATIENTS WERE TREATED WITH URGENT DEVICE REPLACEMENT. BOTH PATIENTS BEGAN TO RECOVER RAPIDLY WITHIN A FEW HOURS OF THE APPROPRIATE HARDWARE BEING REPLACED. IT WAS NOTED THAT ONE PATIENT WAS A (B)(6) FEMALE AND THE OTHER PATIENT WAS A (B)(6) FEMALE. IT WAS NOT SPECIFIED WHICH PATIENT¿S SYMPTOMS WERE DUE TO THE DAMAGED LEAD CONNECTOR AND WHICH PATIENT¿S SYMPTOMS WERE DUE TO THE BATTERY DEPLETION. THIS EVENT WAS REPORTED IN MULTIPLE LITERATURE ARTICLES;

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316240 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R