BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5185415 · Received October 28, 2015

    Report

    Report Number
    3007566237-2015-03132
    Event Type
    Injury
    Date Received
    October 28, 2015
    Date of Event
    September 7, 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

    PLEASE NOTE THIS DATE IS BASED OFF OF THE ARTICLE¿S PUBLICATION DATE AS THE SPECIFIC EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENTS 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. 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. PRODUCT ID: 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    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 ENERGYDISPERSIVEX- 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铠IMPAIRMENT AS WELL AS TO IMPROVE THE BIO-STABILITY OF DBS SYSTEMS. REPORTED EVENTS: IT WAS REPORTED A MALE PRIMARY EARLY-ONSET GENERALIZED DYSTONIA (DYT1) PATIENT WHO WAS LATER TREATED WITH BILATERAL DEEP BRAIN STIMULATION (DBS) OF THE GLOBUS PALLIDUS INTERNUS (GPI) HAD A CLINICAL HISTORY THAT STARTED AT THE AGE OF 3 WITH A PROGRESSIVE SPASTIC PARAPARESIS ASSOCIATED TO DYSTONIC MOVEMENTS OF THE RIGHT UPPER ARM. THE CLINICAL PICTURE PROGRESSIVELY WORSENED AND A GENERALIZED DYSTONIA APPEARED. A DIAGNOSIS OF PRIMARY DYT1- DYSTONIA WAS POSED (BURKE-FAHN-MARSDEN DYSTONIA RATING SCALE (BFMDRS) SEVERITY SCORE: 79.5; DISABILITY: 19). A DRUG-RESISTANT STATUS DISTONICUS (SD) APPEARED AT THE AGE OF 10. BILATERAL GPI-DBS WAS PERFORMED IN 2002; IMPLANTABLE NEUROSTIMULATORS (INSS) WERE SWITCHED ON AND 2 DAYS LATER THE SD DISAPPEARED (BFMDRS SEVERITY SCORE: 63; DISABILITY: 10). IN 2011, AN INFECTION OF THE CONNECTION CABLE OCCURRED; ANTIBIOTIC TREATMENT WAS NOT EFFECTIVE AND REMOVAL OF THE CABLE BECAME NECESSARY, FOLLOWED BY DYSTONIA WORSENING. INFECTION EXTENDED TO THE INSS AND SUCCESSIVELY TO THE EXTRACRANIAL PORTION OF THE LEAD. IT WAS STATED THE PATIENT HAD EXPERIENCED "MULTIPLE AND PROLONGED EXTRACRANIAL DBS SYSTEM INFECTIONS CAUSED BY SERRATIA MARCESCENS" WHICH LED TO THE REMOVAL OF THE ELECTRODE. THE PATIENT UNDERWENT THE REMOVAL OF THE ENTIRE LEFT DBS SYSTEM IN 2012 AND A FEW MONTHS LATER A LEFT PALLIDOTOMY WAS PERFORMED AND RESULTED IN IMPROVEMENT OF THE DISEASE. THIRD PARTY ANALYSIS OF THE LEAD WAS THEN CONDUCTED AT A LATER DATE. A MACROSCOPIC INSPECTION OF THE LEAD DID NOT SHOW ANY ALTERATIONS AND IMPEDANCE TESTING REVEALED THE NORMAL CONDUCTIVITY OF THE LEAD WAS PRESERVED. MORPHOLOGICAL ANALYSIS OF THE LEAD WAS THEN PERFORMED USING SCANNING ELECTRON MICROSCOPY (SEM) AT 347X ZOOM AND FOUND "CRACK-LIKE FORMS, ALWAYS PERPENDICULAR TO THE LEAD DIRECTION" AND RESULTED IN A MORE EVIDENT DISAPPEARANCE OF THE CLASSICAL SMOOTH SURFACE. THERE WAS NO OBSERVED COMMUNICATION BETWEEN THE INNER PART OF THE LEAD AND THE EXTERNAL LEAD. IT WAS NOTED THAT "ONLY A SUPERFICIAL PART OF THE OUTER JACKET TUBING WAS SEVERELY DETERIORATED." EXPLORATION OF THE INTERNAL INSULATING JACKET WAS PERFORMED AFTER THE OUTER JACKET WAS CAREFULLY REMOVED AND FOUND THE ELECTRODE JACKET WAS WELL PRESERVED AND DID NOT SHOW ANY ALTERATIONS WHEN COMPARED TO A NEW LEAD. ENERGY-DISPERSIVE X-RAY SEPECTROSCOPY (EDX) OF THE LEAD NOTED "A TENDENCY OF THE NITROGEN/CARBON RATIO TO INCREASE" WITH IMPLANT DURATION WHEN COMPARED TO A NEW, NEVER IMPLANTED LEAD. IT WAS STATED THAT "MATERIAL DEGRADATION PROGRESSED AS THE DEVICE REMAINED IMPLANTED IN VIVO" AND THAT "THE WEAR OF THE POLYURETHANE EXTERNAL PART OF THE ELECTRODE WAS DIRECTLY CORRELATED WITH THE DURATION OF IMPLANTATION PERIOD." THE AUTHOR NOTED THAT AFTER HAVING BEEN IMPLANTED FOR 10 YEARS, ENVIRONMENTAL BIODEGRADATION (EB) WAS NOTABLE. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715429 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