BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2393428 · Received December 30, 2011

    Report

    Report Number
    3007566237-2011-09390
    Event Type
    Malfunction
    Date Received
    December 30, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALLERT, N., MARKOU, M., MISKIEWICZ, A., A., NOLDEN, L., KARBE, H. ELECTRODE DYSFUNCTIONS IN PATIENTS WITH DEEP BRAIN STIMULATION: A CLINICAL RETROSPECTIVE STUDY. ACTA NEUROCHIR (WIEN). 2011;153(12):2343-2349. PUBLISHED ONLINE OCTOBER 12, 2011. DOI 10.1007/S00701-011-1187-Y. SUMMARY: THIS STUDY EVALUATED THE FREQUENCY AND CLINICAL IMPLICATIONS OF ABNORMAL IMPEDANCE MEASUREMENTS. THE AUTHORS RETROSPECTIVELY ANALYZED FINDINGS OF IMPEDANCE CHECKS IN 591 CONSECUTIVE PATIENTS WITH DEEP BRAIN STIMULATION (DBS) FOR VARIOUS MOVEMENT DISORDERS TREATED BETWEEN 2005 AND 2010. DISORDERS INCLUDED PARKINSON'S DISEASE (423 PATIENTS, 132 FEMALE/291 MALE), DYSTONIA (105 PATIENTS, 45 FEMALE/60 MALE), MULTIPLE SCLEROSIS (19 PATIENTS, 11 FEMALE/8 MALE), ESSENTIAL TREMOR (31 PATIENTS, 12 FEMALE/19 MALE), AND OTHER DISORDERS (13 PATIENTS, 8 FEMALE/5 MALE). TECHNICAL DYSFUNCTIONS INCLUDED SHORT CIRCUITS, DISCONNECTIONS OF A SINGLE CONTACT OR LOOSE CONTACTS. TECHNICAL DYSFUNCTIONS WERE FOUND IN 36 OUT OF 1,142 ELECTRODES AND, AFTER REPLACEMENT OF THE IMPULSE GENERATOR, ANOTHER 16 ELECTRODES REVEALED TECHNICAL DYSFUNCTIONS. SURGERY WAS PERFORMED IN FOUR CASES WHEREAS IN THE OTHER CASES, ADJUSTMENT OF STIMULATION PARAMETERS RESULTED IN EFFECTIVE SYMPTOM CONTROL. THE AUTHORS CONCLUDED THAT TECHNICAL DYSFUNCTIONS OR ELECTRODES OR EXTENSIONS ARE RARE BUT IMPORTANT SOURCES OF UNSATISFACTORY DBS EFFICACY AND THAT REPROGRAMMING WAS AN EFFECTIVE RESOLUTION IN THE MAJORITY OF CASES. REPORTED EVENT: A FEMALE PATIENT WAS OPERATED ON AT THE (B)(6) BECAUSE OF A 5-YEAR HISTORY OF A SEVERE RIGHT-SIDED PD TREMOR. LEFT HEMISPHERIC VIM DBS RESULTED IN ALMOST COMPLETE TREMOR REDUCTION. IMPEDANCES OF ALL CONTACTS WERE NORMAL AFTER SURGERY, AND A BIPOLAR STIMULATION OF CONTACTS 0 AND 1 AS ANODE AND 2 AS CATHODE WITH 130 HZ, 60 S AND 5.4 V WAS PROGRAMMED. AFTER 4 MONTHS SHE NOTICED A REOCCURRENCE OF THE RIGHT-SIDED TREMOR. THE IMPEDANCE CHECK OF CONTACT 0 WAS >2,000 OHM (1,511 OHM IN THE PREVIOUS MEASUREMENT), AND, MOST NOTABLY, THE THRESHOLD OF SIDE EFFECTS (DYSAESTHESIAS) IN A MONOPOLAR STIMULATION SETTING WITH CONTACT 0 ALONE INCREASED FROM 2.0 V DURING THE INITIAL PROGRAMMING TO 7.0 V. REPROGRAMMING TO A BIPOLAR SETTING WITH 1 AS CATHODE AND 2 AS ANODE, LATER EXTENDED TO 1 AND 2 AS CATHODE AND 3 AS ANODE (130 HZ, 6.0 V), RESULTED IN SATISFYING AND STABLE TREMOR REDUCTION DURING THE NEXT 1 AND 1/2-YEAR FOLLOW-UP PERIOD. SEE LITERATURE ARTICLE ATTACHED IN MFR REPORT# 3007566237-2011-09387.

    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 LEAD MODEL NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL#