BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTIMULATOR

    MDR report key: 2497564 · Received March 20, 2012

    Report

    Report Number
    3007566237-2012-00584
    Event Type
    Injury
    Date Received
    March 20, 2012
    Date of Event
    December 28, 2011
    Report Date
    March 14, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONTINUED FROM CONCOMITANT MEDICAL PRODUCTS: LEAD MODEL UNKNOWN LOT# UNKNOWN IMPLANTED: UNKNOWN EXPLANTED: UNKNOWN; EXTENSION MODEL UNKNOWN SERIAL# UNKNOWN IMPLANTED: UNKNOWN EXPLANTED: UNKNOWN. THE ACTUAL EVENT DATES WERE NOT PROVIDED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: LONG TERM FOLLOW-UP OF DEEP BRAIN STIMULATION OF THE CAUDAL ZONA INCERTA FOR ESSENTIAL TREMOR. ANDERS FYTAGORIDIS, ULRIKA SANDVIK, MATTIAS ASTROM, TOMMY BERGENHEIM, PATRIC BLOMSTEDT. J NEUROL NEUROSURG PSYCHIATRY 2012;83:258E262. DOI:10.1136/JNNP-2011-300765. ABSTRACT: PURPOSE: THE VENTRAL INTERMEDIATE NUCLEUS OF THALAMUS IS THE STANDARD TARGET FOR DEEP BRAIN STIMULATION (DBS) IN ESSENTIAL TREMOR (ET). HOWEVER, FAVOURABLE DATA HAVE RECENTLY HIGHLIGHTED THE CAUDAL ZONA INCERTA (CZI) AS AN ALTERNATIVE TARGET. REPORTS CONCERNING THE LONG-TERM RESULTS ARE, HOWEVER, LACKING, AND WE HAVE, THEREFORE, EVALUATED THE LONG-TERM EFFECTS IN OUR PATIENTS WITH ET AND CZI DBS. METHODS: 18 PATIENTS WERE EVALUATED USING THE ESSENTIAL TREMOR RATING SCALE (ETRS) BEFORE AND ON-/OFF STIMULATION AT 1 AND 3-5 YEARS AFTER SURGERY (MEAN 48.5610.6 MONTHS). TWO PATIENTS WERE OPERATED ON BILATERALLY BUT ALL ELECTRODES WERE EVALUATED SEPARATELY. THE STIMULATION PARAMETERS WERE RECORDED AND THE STIMULATION STRENGTH CALCULATED. RESULTS: A BASELINE TOTAL ETRS MEAN SCORE OF 46.0 DECREASED TO 21.9 (52.4%) AT THE FINAL EVALUATION. ON THE TREATED SIDE, TREMOR OF THE UPPER EXTREMITY (ITEM 5 OR 6) IMPROVED FROM 6.1 TO 0.5 (91.8%) AND HAND FUNCTION (ITEMS 11-14) IMPROVED FROM 9.3 TO 2.0 (78.0%). ACTIVITIES OF DAILY LIVING IMPROVED BY 65.8%. THERE WAS NO INCREASE IN STIMULATION STRENGTH OVER TIME. CONCLUSION: CZI DBS IS A SAFE AND EFFECTIVE TREATMENT FOR THE LONG TERM SUPPRESSION OF ET. REPORTABLE EVENTS: ONE PATIENT WAS OPERATED ON WITH BILATERAL REVISION OF THE EXTENSION CABLES DUE TO STRAIN IN THE NECK. THE IMPLANTABLE PULSE GENERATOR WAS REPLACED SIMULTANEOUSLY ALTHOUGH IT WAS NOT YET DEPLETED. THERE WERE NO ADDITIONAL COMPLICATIONS OR BATTERY REPLACEMENTS DURING THE LONG TERM FOLLOW-UP. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: THE OPERATIONS WERE FRAME BASED STEREOTACTIC IMPLANTATIONS OF THE DBS ELECTRODE 3387 OR 3389. 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
    1 NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention