BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4812083 · Received June 2, 2015

    Report

    Report Number
    3007566237-2015-01508
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    January 22, 2015
    Report Date
    May 5, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT PRODUCTS: PRODUCT ID NEU_INS_STIMULATOR, LOT # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT # UNKNOWN, PRODUCT ID 3387, LOTN# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    BRECL JAKOB, G., PELYKH, O., KOSUTZKA, Z., PIRTO¿EK, Z., TRO¿T, M., ILMBERGER, J., VALKOVIC, P., MEHRKENS, J.H., BÖTZEL, K. POSTURAL STABILITY UNDER GLOBUS PALLIDUS INTERNUS STIMULATION FOR DYSTONIA. CLINICAL NEUROPHYSIOLOGY : OFFICIAL JOURNAL OF THE INTERNATIONAL FEDERATION OF CLINICAL NEUROPHYSIOLOGY. 1388;2015 FEB 16. SUMMARY: DEEP BRAIN STIMULATION OF THE GLOBUS PALLIDUS INTERNUS (GPI-DBS) IS AN EFFICIENT AND SAFE TREATMENT FOR MEDICALLY REFRACTORY DYSTONIA. HOWEVER, RECENT STUDIES REPORTED GAIT PROBLEMS, FALLS AND BRADYKINESIA IN PATIENTS AFTER THE DBS PROCEDURE. THE AIM OF THIS STUDY WAS TO QUANTIFY THE EFFECT OF GPI-DBS ON POSTURAL PERFORMANCE IN PATIENTS WITH CRANIO-CERVICAL DYSTONIA. THIRTEEN PATIENTS WITH FOCAL/SEGMENTAL DYSTONIA AND GPI-DBS PARTICIPATED IN THE STUDY. WE PERFORMED TWO POSTURAL TESTS (PULL TEST AND PUSH AND RELEASE TEST) IN ON- AND OFF-STIMULATION CONDITIONS AND RECORDED THE MOVEMENTS OF THE PATIENTS WITH INERTIAL SENSORS. UNDER STIMULATION PATIENTS EXHIBITED A HIGHER NUMBER OF STEPS (P = 0.015), REDUCED FIRST STEP LENGTH (P = 0.011) AND LOWER STEPPING VELOCITY (P = 0.001), COMPARED TO OFF STIMULATION. WE OBSERVED A HIGHER NUMBER OF STEPS IN THE PUSH AND RELEASE TEST COMPARED TO THE PULL TEST (P = 0.038). THE INTERACTION BETWEEN STIMULATION CONDITION AND TEST TYPE WAS SIGNIFICANT (P = 0.027). THE VELOCITY AND AMPLITUDE OF POSTURAL REACTIONS ARE COMPROMISED BY GPI-DBS IN PATIENTS WITH CRANIO-CERVICAL DYSTONIA. THIS INFORMATION CORRESPONDS TO PATIENT¿S REPORTS OF FALLS AND POSTURAL INSTABILITY AFTER GPI- DBS. PRE-OPERATIVELY, PATIENTS SHOULD BE INFORMED ABOUT THE POSSIBILITY OF THE OCCURRENCE OF SUCH PHENOMENA. REPORTED EVENT: 1 PATIENT WITH DEEP BRAIN STIMULATION (DBS) FOR DYSTONIA HAD A SLIGHT HEMIPARESIS DUE TO A MINOR STROKE AND SLIGHT SPASTIC PARAPARESIS DUE TO CERVICAL SPINAL STENOSIS. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: LEAD MODEL 3387 FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356954 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention