BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5187541 · Received October 29, 2015

    Report

    Report Number
    3007566237-2015-03133
    Event Type
    Injury
    Date Received
    October 29, 2015
    Date of Event
    September 7, 2015
    Report Date
    September 29, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_EXT LOT# UNKNOWN, PRODUCT TYPE: EXTENSION. (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 ENERGY DISPERSIVE 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 FEMALE EPILEPSY PATIENT WHO WAS LATER TREATED WITH DEEP BRAIN STIMULATION (DBS) OF THE LEFT CAUDAL ZONA INCERTA (CZI) HAD INITIALLY BEGAN EXPERIENCING SEIZURES IN 2003. CORTICAL AND SUBCORTICAL BIOPSIES OF THE LEFT FRONTAL LOBE SUGGESTED THAT RASMUSSEN ENCEPHALITIS WAS THE ETIOLOGY. FOUR YEARS AFTER THE ONSET, THE PATIENT DEVELOPED A DRUG-RESISTANT EPILEPSIA PARTIALIS CONTINUA (EPC). GIVEN THAT COGNITIVE, MOTOR, AND LANGUAGE FUNCTIONS WERE GOOD, A LEFT CZI DBS WAS PROPOSED IN OCTOBER 2007 AND SIGNIFICANT IMPROVEMENTS IN THE FREQUENCY OF SEIZURES WAS REPORTED FOR THE (B)(6) YEAR OLD PATIENT. IN 2009, THE PATIENT "HAD AN EPC REFRACTORY TO THE STIMULATION PARAMETERS ARRANGEMENT TO THE ANTI-EPILEPTIC DRUG (AED) DOSE AUGMENTATION AND TO THE IMMUNOMODULATORY TREATMENT." INTERROGATION OF THE PATIENT'S DBS SYSTEM REVEALED CORRECT IMPEDANCE VALUES AND DID NOT SHOW ANY OTHER SIGNS OF MALFUNCTIONING. THUS, THE LEFT MOTOR CORTEX WAS SURGICALLY REMOVED AND THE SEIZURES WERE COMPLETELY CONTROLLED. MOREOVER, THE PATIENT HAD REQUESTED FOR THE DBS SYSTEM TO BE SWITCHED OFF BECAUSE IT WAS INEFFECTIVE. IN MARCH 2013, THE ENTIRE DBS SYSTEM WAS EXPLANTED. 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 "STAR-LIKE FORMS THAT APPEARED TO BE MORE EVIDENT AT THE LEVEL OF THE JACKET NEAR THE STIMULATING CONTACT." 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 WELL PRESERVED AND DID NOT SHOW ANY ALTERATIONS WHEN COMPARED TO A NEW LEAD. ENERGY-DISPERSIVE X-RAY SPECTROSCOPY (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." 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
    719614 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention