BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5181906 · Received October 27, 2015

    Report

    Report Number
    3007566237-2015-03117
    Event Type
    Injury
    Date Received
    October 27, 2015
    Report Date
    September 29, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT PATIENT CODE (B)(4) WAS REPORTED IN ERROR AND HAS BEEN REMOVED FROM THIS REPORT.

    Description of Event or Problem · 1

    RIZZI, M., DE BENEDICTIS, A., MESSINA, G., CORDELLA, R., MARCHESI, D., MESSINA, R., PENNER, F., FRANZINI, A., MARRAS, C.E. COMPARATIVE ANALYSIS OF EXPLANTED DBS ELECTRODES. ACTA NEUROCHIRURGICA. 2015. DOI 10.1007/S00701-015-2572-8 SUMMARY: HARDWARE-RELATED COMPLICATIONS FREQUENTLY OCCUR IN DEEP BRAIN STIMULATION. MICROSCOPY AND SPECTROSCOPY TECHNIQUES ARE EFFECTIVE METHODS FOR CHARACTERIZING THE MORPHOLOGICAL AND CHEMICAL BASIS OF MALFUNCTIONING DBS ELECTRODES. A PREVIOUS REPORT BY OUR TEAM REVEALED THE MORPHOLOGICAL AND CHEMICAL ALTERATIONS ON A MALFUNCTIONING EXPLANTED ELECTRODE WHEN IT WAS COMPARED TO A NEW DEVICE. THE AIM OF THIS PRELIMINARY STUDY WAS TO VERIFY WHETHER THESE MORPHOLOGICAL AND CHEMICAL ALTERATIONS IN THE MATERIALS WERE A DIRECT RESULT OF THE HARDWARE MALFUNCTIONING OR IF THE FAILURE WAS CORRELATED TO A DEGRADATION PROCESS OVER TIME. TWO DBS ELECTRODES WERE REMOVED FROM TWO PATIENTS FOR REASONS OTHER THAN DBS SYSTEM IMPAIRMENT AND WERE ANALYZED BY A SCANNING ELECTRON MICROSCOPE AND BY AN ENERGYDISPERSIVE X- RAY SPECTROSCOPY. THE RESULTS WERE COMPARED TO A MALFUNCTIONING DEVICE AND TO A NEW DEVICE, PREVIOUSLY ANALYZED BY OUR GROUP. THE ANALYSIS REVEALED THAT THE WEAR OF THE POLYURETHANE EXTERNAL PART OF ALL THE ELECTRODES WAS DIRECTLY CORRELATED WITH THE DURATION OF IMPLANTATION PERIOD. MOREOVER, THESE ALTERATIONS WERE INDEPENDENT FROM THE ELECTRODES FUNCTIONING AND FROM PARAMETERS USED DURING THERAPY. THIS IS THE FIRST STUDY DONE THAT DEMONSTRATES A TIME-RELATED DEGRADATION IN THE EXTERNAL LAYER OF DBS ELECTRODES. THE ANALYSES OF MORPHOLOGICAL AND CHEMICAL PROPERTIES OF THE IMPLANTED DEVICES ARE RELEVANT FOR PREDICTING THE POSSIBILITY OF HARDWARE'S IMPAIRMENT AS WELL AS TO IMPROVE THE BIO-STABILITY OF DBS SYSTEMS. REPORTED EVENTS: IT WAS REPORTED A MALE IDIOPATHIC PRIMARY GENERALIZED DYSTONIA PATIENT WHO WAS LATER TREATED WITH DEEP BRAIN STIMULATION (DBS) OF THE GLOBUS PALLIDUS INTERNUS (GPI) HAD AN INITIAL ONSET OF WALKING DYSTONIA AT THE (B)(6). THE PATIENT WAS DIAGNOSED WITH IDIOPATHIC PRIMARY GENERALIZED DYSTONIA AT (B)(6). DBS OF THE GPI WAS PERFORMED AT THE (B)(6), IN 2005. AFTER RECEIVING DBS THERAPY, THE PATIENT REMARKABLY IMPROVED AND HE WAS WALKING INDEPENDENTLY 1 YEAR LATER (BURKE-FAHN-MARSDEN DYSTONIA RATING SCALE (BFMDRS) SEVERITY SCORE: 66). AT THE AGE OF 19, A WORSENING OF DYSTONIA INVOLVING THE LOWER LIMBS AND THE RIGHT UPPER LIMB APPEARED (BFMDRS: 71); "THE ELECTRODE'S IMPEDANCE WAS HIGHER THAN 2000 OHM." IN (B)(6) 2010, THE PATIENT AGREED TO HAVE THE "FAULTY ELECTRODES" REMOVED AND REPLACED WITH A NEW LEAD ON THE LEFT SIDE. THE PROCEDURE WAS SUCCESSFUL AND WITHOUT COMPLICATIONS. DURING THE LAST FOLLOW-UP ((B)(6) 2014), DBS WAS FOUND TO BE EFFECTIVE IN THE TREATMENT OF HIS DYSTONIC SYMPTOMS (BFMDRS: 60). THIRD PARTY ANALYSIS OF THE LEAD WAS THEN CONDUCTED AT A LATER DATE. A MACROSCOPIC INSPECTION OF THE PATIENT'S LEAD FOUND THAT IN AN EXTRACRANIAL PORTION OF THE LEAD, BROWN COLORED AREAS BENEATH THE EXTERNAL LAYER OF THE LEAD (IE THE OUTER JACKET TUBING) WERE FOUND. "MOREOVER, THE METALLIC COILS APPEARED TO BE DISTORTED AND STRETCHED THROUGHOUT DIFFERENT PARTS OF THE LEAD. "IMPEDANCE TESTING OF THE LEAD FOUND ZERO CONDUCTIVITY. MORPHOLOGICAL ANALYSIS OF THE LEAD WAS THEN PERFORMED USING SCANNING ELECTRON MICROSCOPY (SEM) AT 282X ZOOM AND FOUND "CRACK-LIKE FORMS, PERPENDICULAR TO THE LEAD AXIS, WHICH EXTENDED ABOVE THE LEAD SURFACE." THERE WAS NO OBSERVED COMMUNICATION BETWEEN THE INNER PART OF THE LEAD AND THE EXTERNAL LEAD. EXPLORATION OF THE INTERNAL INSULATING JACKET WAS PERFORMED AFTER THE OUTER JACKET WAS CAREFULLY REMOVED AND FOUND "THE ELECTRODE JACKET WAS COVERED BY REMNANTS OF DEGENERATED MATERIAL." IT WAS STATED THERE WERE "FRAGMENTS OF MATERIAL WITH A MELTED ASPECT PARTIALLY COVERING THE INTERNAL INSULATING JACKET." ENERGY-DISPERSIVE X-RAY SPECTROSCOPY (EDX) OF THE MATERIAL FRAGMENTS FOUND THE AMOUNT OF EACH CHEMICAL ELEMENT WAS "COHERENT WITH THE OCCURRENCE OF A MIXTURE BETWEEN THE POLYURETHANE (FORMING THE OUTER JACKET TUBING) AND FLUOROPOLYMER (FORMING THE INTERNAL INSULATING JACKET)." THE "CHEMICAL STRUCTURE OF THE MATERIAL PARTIALLY COVERING THE INTERNAL INSULATING JACKET IN PATIENT 1 WAS COMPOSED OF 63 % OF CARBON, 3.5 % FLUORINE, 12 % OF OXYGEN, AND 11 % NITROGEN." IN COMPARISON THE COMPOSITION OF ANEW EXTERNAL JACKET AND INTERNAL JACKET WAS 81% OF CARBON, 13% OF OXYGEN, AND 6% OF NITROGEN AND 38% OF CARBON, 61% OF FLUORINE, 1% OF OXYGEN, AND 0.3% OF NITROGEN RESPECTIVELY. IT WAS NOTED THE FINDING SUSTAINED THE HYPOTHESIS THAT THE ALTERATIONS "WERE PROBABLY CAUSED BY A PROCESS THAT ALLOWS THE DETACHMENT AND THE MOLECULAR REARRANGEMENT OF THE LEAD MATERIAL." IT WAS CONCLUDED THAT "THE DEGENERATED MATERIALS FOUND ABOVE THE INTERNAL INSULATING JACKET WERE PROBABLY CORRELATED TO THE LEAD IMPAIRMENT." FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    PLEASE SEE THE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712319 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention