BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3186131 · Received June 24, 2013

    Report

    Report Number
    3007566237-2013-02083
    Event Type
    Injury
    Date Received
    June 24, 2013
    Date of Event
    December 7, 2010
    Report Date
    August 15, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7428, LOT# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 7428, LOT# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3389, LOT# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    PLAHA, P., JAVED, S., AGOMBAR, D., ET AL. BILATERAL CAUDAL ZONA INCERTA NUCLEUS STIMULATION FOR ESSENTIAL TREMOR: OUTCOME AND QUALITY OF LIFE. J NEUROL NEUROSURG PSYCHIATRY. 2011;82(8):899-904. DOI: 10.1136/JNNP.2010.222992 SUMMARY: OVER THE PAST FEW YEARS, BILATERAL STIMULATION OF THE CAUDAL OR MOTOR PART OF THE ZONA INCERTA NUCLEUS (CZI) HAS BEEN PERFORMED BY THE AUTHORS IN PATIENTS WITH ESSENTIAL TREMOR (ET). OUTCOMES INCLUDING QUALITY OF LIFE DATA IN 15 PATIENTS WITH A FOLLOW-UP PERIOD OF UP TO 84 MONTHS (MEAN 31.7628.6 MONTHS) ARE PRESENTED. FIFTEEN CONSECUTIVE ET PATIENTS UNDERWENT MRI GUIDED BILATERAL CZI DEEP BRAIN STIMULATION IMPLANTATION. PATIENTS WERE ASSESSED BY APPLYING THE FAHNETOLOSAE MARIN TREMOR RATING SCALE AND THE SHORT FORM HEALTH SURVEY-36 (SF-36) TO ASSESS QUALITY OF LIFE. RESULTS THE TOTAL TREMOR SCORE IMPROVED BY 73.8% (P<(><<)>0.0001). THE PART A SCORE (ITEMS 1E9) IMPROVED BY 86.6% (P<(> <<)>0.0001). POSTURAL TREMOR IMPROVED BY 88.2% (P<(><<)>0.0001) AND ACTION TREMOR BY 82.2% (P<(><<)>0.0001). THE PART B SCORE, WHICH EVALUATES THE FUNCTIONAL ACTIVITIES OF THE UPPER LIMBS, IMPROVED BY 60.1% (P<(><<)>0.0001). PART C SCORE, WHICH EVALUATES THE ACTIVITIES OF DAILY LIVING, IMPROVED BY 80.0% (P<(><<)>0.0001). THE SF-36 PHYSICAL COMPONENT SCORE IMPROVED BY 23.7% (P<(><<)>0.0001) AND THE MENTAL COMPONENT SCORE BY 22.4% (P<(><<)>0.0001). THERE WAS ONE WOUND INFECTION AND THREE PATIENTS DEVELOPED STIMULATION RELATED TRANSIENT DYSARTHRIA. NONE DEVELOPED ANY DISEQUILIBRIUM OR TOLERANCE TO STIMULATION. BILATERAL CZI STIMULATION IS SAFE AND EFFECTIVE IN SUPPRESSING THE POSTURAL AND ACTION COMPONENT OF ET. IT IS ASSOCIATED WITH A LOW INCIDENCE OF STIMULATION RELATED COMPLICATIONS AND PATIENTS DO NOT DEVELOP TOLERANCE TO STIMULATION WITH MAINTAINED CLINICAL BENEFIT OVER A FOLLOW-UP PERIOD OF UP TO 7 YEARS. REPORTED EVENTS: 1 PATIENT HAD A WOUND INFECTION ON THE BACKGROUND OF INSULIN DEPENDENT DIABETES. THE SYSTEM WAS EXPLANTED AND REPLACED AFTER 8 WEEKS FOLLOWING ANTIBIOTIC TREATMENT. 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
    285156 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7428 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention