BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2390278 · Received December 28, 2011

    Report

    Report Number
    3007566237-2011-09357
    Event Type
    Injury
    Date Received
    December 28, 2011
    Report Date
    December 1, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: WN IMPLANTED: UNK EXPLANTED: UNK; LEAD MODEL NEU_UNKNOWN_EXT LOT# UNK SERIAL# UNKNOWN IMPLANTED: UNK EXPLANTED: UNK; LEAD MODEL 3389 LOT# UNKNOWN SERIAL# UNK IMPLANTED: UNK EXPLANTED: UNK; LEAD MODEL 3389 LOT# UNKNOWN SERIAL# UNK IMPLANTED: UNK EXPLANTED: UNK.

    Description of Event or Problem · 1

    LITERATURE: BLOMSTEDT, P., SANDVIK, U., LINDER, J., FREDRICKS, A., FORSGREN, L., HARIZ, M. I. DEEP BRAIN STIMULATION OF THE SUBTHALAMIC NUCLEUS VERSUS THE ZONA INCERTA IN THE TREATMENT OF ESSENTIAL TREMOR. ACTA NEUROCHIR (WIEN). 2011;153(12):2329-2335. PUBLISHED ONLINE SEPTEMBER 10, 2011. DOI 10.1007/S00701-011-1157-4. SUMMARY: THE AUTHORS EVALUATE THE EFFICACY OF DEEP BRAIN STIMULATION (DBS) IN THE SUBTHALAMIC NUCLEUS (STN) VS. CAUDAL ZONA INCERTA (CZI) DBS FOR PATIENTS WITH ESSENTIAL TREMOR (ET). FOUR PATIENTS WITH ET WERE IMPLANTED WITH TWO IPSILATERAL ELECTRODES, ONE IN THE STN AND ONE IN THE CZI. PATIENTS WERE RANDOMIZED TO STN OR CZI STIMULATION FOR 3 MONTHS, AFTER WHICH THEY WERE SWITCHED TO THE OTHER ELECTRODE. THE EFFECTS OF STIMULATION WERE EVALUATED USING THE ESSENTIAL TREMOR RATING SCALE (ETRS) BEFORE SURGERY, AND ON AND OFF STIMULATION AFTER 4, 7 AND 12 MONTHS. AT THE ONE YEAR FOLLOW-UP AN EVALUATION WAS PERFORMED DURING WHICH ALL LEAD CONTACTS WERE ANALYZED USING HAND TREMOR AND HAND FUNCTION WHILE VOLTAGE WAS INCREASED UNTIL THE BEST EFFECT OF TREMOR WAS ACHIEVED. STN AND CZI BOTH PROVED TO BE POTENT TARGETS, BUT CZI WAS MORE EFFICIENT BECAUSE THE SAME DEGREE OF TREMOR REDUCTION COULD BE ACHIEVED WITH LOWER ENERGY CONSUMPTION. REPORTED EVENT: THE PATIENT WAS A (B)(6) MALE WITH A FAMILY HISTORY OF ET WHOSE TREMOR STARTED IN THE LEFT HAND 4 YEARS PRIOR TO SURGERY. AFTER 3 MONTHS OF CZI STIMULATION, THE PATIENT WAS FREE OF TREMOR IN THE TREATED SIDE. UPON SWITCHING TO STN DBS, NO TREMOR COULD BE SEEN. AFTER A FEW DAYS THE PATIENT DEVELOPED STIMULATION-INDUCED DYSTONIA IN THE CONTRALATERAL LEG AND STOPPED PARTICIPATION IN THE RANDOMIZED PART OF THE STUDY. DUE TO A MALFUNCTION OF THE IPG (DETAILS NOT PROVIDED), CONTACTS 2 AND 3 ON THE CZI ELECTRODE COULD NOT BE USED FOR STIMULATION. THE PATIENT DID FURTHER COMPLAIN ABOUT NECK TENSION, THEREFORE THE CONNECTION CABLE TO THE STN ELECTRODE WAS REMOVED. SIX YEARS AFTER SURGERY, THE PATIENT IS FREE OF TREMOR IN THE TREATED SIDE ON STIMULATION, WHILE TOTAL ETRS HAD INCREASED OFF-STIMULATION BECAUSE OF PROGRESSION OF TREMOR IN THE NON-TREATED SIDE. THE CONTACT EVALUATION PERFORMED AFTER SURGERY DEMONSTRATED THE EFFECT ON TREMOR TO BE BEST IN THE CZI ELECTRODE, EVEN THOUGH THE PATIENT ALSO BECAME FREE OF TREMOR WHEN THE STN ELECTRODE WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL NEU_UNKNOWN_EXT LOT# UNK SERIAL# UNKNO