BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

    MDR report key: 5651522 · Received May 12, 2016

    Report

    Report Number
    3007566237-2016-01963
    Event Type
    Malfunction
    Date Received
    May 12, 2016
    Date of Event
    August 1, 2004
    Report Date
    May 12, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT AGE: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PT GENDER: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE MONTH AND YEAR OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. 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

    COUBES, P., CIF, L., EL FERTIT, H., HEMM, S., VAYSSIERE, N., SERRAT, S., PICOT, M.C., TUFFERY, S., CLAUSTRES, M., ECHENNE, B., FREREBEAU, P. ELECTRICAL STIMULATION OF THE GLOBUS PALLIDUS INTERNUS IN PATIENTS WITH PRIMARY GENERALIZED DYSTONIA: LONG-TERM RESULTS. J NEUROSURG. 2004. 101:189¿194. SUMMARY: PRIMARY GENERALIZED DYSTONIA (PGD) IS A MEDICALLY REFRACTORY DISEASE OF THE BRAIN CAUSING TWISTING OR SPASMODIC MOVEMENTS AND ABNORMAL POSTURES. IN MORE THAN 30% OF CASES IT IS ASSOCIATED WITH THE AUTOSOMAL DYT1 MUTATION. CONTINUOUS ELECTRICAL STIMULATION OF THE GLOBUS PALLIDUS INTERNUS (GPI) HAS BEEN USED SUCCESSFULLY IN THE TREATMENT OF PGD. THE AIM OF THIS STUDY WAS TO EXAMINE THE LONG-TERM EFFICACY AND SAFETY OF DEEP BRAIN STIMULATION (DBS) IN THE TREATMENT OF PGD IN CHILDREN AND ADULTS WITH AND WITHOUT THE DYT1 MUTATION. REPORTED EVENTS: AN UNKNOWN NUMBER OF PATIENTS WITH BILATERAL GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) FOR PRIMARY GENERALIZED DYSTONIA HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) UNEXPECTEDLY SWITCHED OFF, RESULTING IN A RECURRENCE OF THEIR UNDERLYING SYMPTOMS, WHICH DISAPPEARED AGAIN QUICKLY UPON REACTIVATION OF STIMULATION. THE AUTHORS NOTED THAT PATIENTS WERE BILATERALLY IMPLANTED WITH A PAIR OF 3389 ELECTRODES, WHICH WERE CONNECTED TO EITHER AN ITREL II OR III NEUROSTIMULATOR. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE (SUCH AS SERIAL NUMBERS) OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306586 IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR