BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4334074 · Received December 16, 2014

    Report

    Report Number
    3004209178-2014-24046
    Event Type
    Injury
    Date Received
    December 16, 2014
    Date of Event
    January 1, 2011
    Report Date
    November 24, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE EXACT EVENT DATE WAS NOT PROVIDED. ONLY THE MONTH AND YEAR ARE VALID. CONCOMITANT PRODUCTS: PRODUCT ID 3389, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    COENEN, V.A., ALLERT, N., PAUS, S., KRONENBURGER, M., URBACH, H., MADLER, B. MODULATION OF THE CEREBELLO-THALAMO-CORTICAL NETWORK IN THALAMIC DEEP BRAIN STIMULATION FOR TREMOR: A DIFFUSION TENSOR IMAGING STUDY. NEUROSURGERY. 2014. DOI:10.1227/NEU.0000000000000540. SUMMARY: DEEP BRAIN STIMULATION ALLEVIATES TREMOR OF VARIOUS ORIGINS. SEVERAL REGIONS LIKE THE VENTRALIS INTERMEDIATE NUCLEUS OF THALAMUS, THE CAUDAL ZONA INCERTA, AND THE POSTERIOR SUBTHALAMIC REGION ARE GENERALLY TARGETED. PREVIOUS WORK WITH FIBER TRACTOGRAPHY HAS SHOWN THE INVOLVEMENT OF THE CEREBELLO-THALAMO-CORTICAL NETWORK IN TREMOR CONTROL. TO REPORT THE RESULTS OF A PROSPECTIVE TRIAL IN A GROUP OF TREMOR PATIENTS THAT UNDERWENT POSTHOC TRACTOGRAPHIC ANALYSIS AFTER TREATMENT WITH TRADITIONAL THALAMIC DEEP BRAIN STIMULATION. A TOTAL OF 11 PATIENTS (AGED 64+/-17 YEARS, 6 MALE) WERE ENROLLED (ESSENTIAL TREMOR (6), PARKINSON¿S TREMOR (3) AND MYOCLONIC TREMOR IN MYOCLONUS DYSTONIA (2)). PATIENTS RECEIVED ONE (3), TWO (7), OR THREE (1) QUADRIPOLAR ELECTRODES. A 32-DIRECTION DIFFUSION TENSOR MAGNETIC RESONANCE IMAGING SEQUENCE WAS ACQUIRED PREOPERATIVELY. TRACTOGRAPHY WAS PROCESSED POSTOPERATIVELY FOR EVALUATION AND THE DENTATO-RUBRO-THALAMIC TRACT (DRT) WAS INDIVIDUALLY TRACKED. ELECTRODE POSITIONS WERE DETERMINED WITH HELICAL CT. ELECTRIC FIELDS (EFS) WERE SIMULATED ACCORDING TO INDIVIDUAL STIMULATION PARAMETERS IN A STANDARDIZED ATLAS BRAIN SPACE (ICBM-MNI152). TREMOR WAS REDUCED IN ALL PATIENTS (69.4% MEAN) ON THE GLOBAL (BILATERAL) TREMOR SCORE. EFFECTIVE CONTACTS WERE LOCATED INSIDE OR IN PROXIMITY TO THE DRT. IN MODERATE TREMOR REDUCTION (2 PATIENTS) THE EFS WERE CENTERED ON ITS ANTERIOR BORDER. IN GOOD AND EXCELLENT TREMOR REDUCTION (9 PATIENTS) EFS FOCUSED ON ITS CENTER. DBS OF THE CEREBELLO-THALAMO-CORTICAL NETWORK REDUCES TREMOR. THE DRT CONNECTS THREE TRADITIONAL TARGET REGIONS FOR DEEP BRAIN STIMULATION IN TREMOR DISEASE. TRACTOGRAPHY TECHNIQUES CAN BE USED TO DIRECTLY VISUALIZE THE DRT AND, THEREFORE, OPTIMIZE TARGET DEFINITION IN INDIVIDUAL PATIENTS. REPORTED EVENT: 1 PATIENT EXPERIENCE WOUND-HEALING DISTURBANCES AND HAD TO BE SURGICALLY TREATED. IT WAS NOTED THAT THERE WAS EROSION AT THE DEEP BRAIN STIMULATOR SITE. THE SYSTEM REPORTEDLY REMAIN INTACT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A CONFIRMED INFECTION. IT WAS NOTED THAT THE CAUSE OF THE EROSION WAS DETERMINED TO BE DUE TO THE CONNECTION CABLE THAT WAS USED BEING TOO SHORT AND THE IMPLANTABLE NEUROSTIMULATOR (INS) BEING TOO SHARP. THE PATIENT UNDERWENT A SURGICAL REVISION AND ANTIBIOTICS, THEN A SECOND SURGICAL REVISION WITH EXPLANT OF THE DEVICE. THE PATIENT THEN RECEIVED ADDITIONAL ANTIBIOTICS AND EVENTUALLY HAD A NEW SYSTEM IMPLANTED. THE INFECTION RESOLVED FOLLOWING THE EXPLANT OF THE SYSTEM. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY AND WAS NOTED TO BE ¿FINE WITHOUT SEQUELAE.¿ IT WAS NOTED THAT THERE WERE NO OBSERVED DEVICE MALFUNCTIONS. PLEASE NOTE THAT THIS EVENT WAS PREVIOUSLY REPORTED IN MANUFACTURING REPORT # 3007566237-2014-02897. DUE TO FOLLOW-UP INFORMATION RECEIVED, ANY ADDITIONAL INFORMATION REGARDING THIS EVENT WILL BE REPORTED UNDER THIS NEW MANUFACTURING REPORT NUMBER. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: ACTIVA PC MODEL 37601 AND LEADS MODEL 3389.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824223 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention