BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4841452 · Received June 12, 2015

    Report

    Report Number
    3007566237-2015-01642
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    September 6, 2014
    Report Date
    May 21, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    CORTESE F, ROSA M, ARLOTTI M, COGIAMANIAN F, ARDOLINO G, RAMPINI P, CARRABBA G, LOCATELLI M, LEVI V, PRIORI A. ABNORMAL LOCAL FIELD POTENTIALS PRECEDE CLINICAL COMPLICATIONS AFTER DBS SURGERY FOR PARKINSON¿S DISEASE: A CASE REPORT. CLINICAL NEUROPHYSIOLOGY 126 (2015) 1056-1058 DOI: 10.1016/J.CLINPH.2014.08.013. SUMMARY/REPORTED EVENT: ONE PATIENT UNDERWENT IMPLANT OF BILATERAL DEEP BRAIN STIMULATION (DBS) ELECTRODES IN THE SUBTHALAMIC NUCLEUS (STN) FOR TREATMENT OF PARKINSON¿S DISEASE. IMMEDIATELY AFTER SURGERY, A CT SCAN WAS PERFORMED: NO SURGICAL COMPLICATIONS WERE DETECTED. THE LOCAL FIELD POTENTIALS (LFP) RECORDING SESSION, ABOUT 48 HOURS AFTER SURGERY, SHOWED THAT THE MEAN LFP AMPLITUDE WAS CLEARLY LOWER IN THE RIGHT THAN IN THE LEFT STN. MOREOVER, THE LFP VALUE RECORDED FOR THE RIGHT STN WAS IN THE LOWER LIMITS OF THE NORMAL LFP AMPLITUDE RANGE. THE MEAN IMPEDANCE RECORDED FROM THE MACROELECTRODE CONTACT PAIRS WAS ALMOST SYMMETRIC (RIGHT=8.58 K-OHMS, LEFT = 10.80 K-OHMS). THE DAY AFTER THE FIRST RECORDING SESSION, THE PATIENT STARTED TO COMPLAIN OF WALKING PROBLEMS AND TENDED TO FALL TOWARD THE LEFT SIDE. NEUROLOGICAL EXAMINATION FOUND A SLIGHT WEAKNESS IN THE LEFT LIMBS, WITH MILD PRONATION AND DISTAL WEAKNESS IN THE LEFT UPPER LIMB, AND A SLIGHT CENTRAL LEFT FACIAL-NERVE PARALYSIS. THERE WAS AN ABNORMAL EXTENSOR PLANTAR RESPONSE (BABINSKI SIGN) ON THE LEFT. SENSITIVITY, COORDINATION, AND OCULAR MOTILITY WERE NORMAL. THE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE WAS 3/42. THE PATIENT UNDERWENT A CT BRAIN SCAN WHICH SHOWED A SMALL HYPERDENSE HEMORRHAGIC AREA LOCALIZED JUST CAUDALLY TO THE ELECTRODE APEX AND A SLIGHT HYPODENSITY IN THE RIGHT CEREBRAL PEDUNCLE AND MIDBRAIN, EXTENDING THROUGH THE RIGHT PONS. IT WAS NOTED THAT THE SLIGHT HYPO DENSITY IN THE RIGHT CEREBRAL PEDUNCLE AND MIDBRAIN AND EXTENDING THROUGH THE PONS PROBABLY REFLECTED EDEMA BECAUSE IT CAUSED ONLY MILD NEUROLOGICAL DEFICITS AND WAS FULLY REVERSIBLE 30 DAYS AFTER THE EVENT. A SECOND LFP RECORDING SESSION WAS PERFORMED SEVEN DAYS AFTER DBS SURGERY. IN THE SECOND RECORDING SESSION (ABOUT 168 HOURS AFTER SURGERY) THE LFP AMPLITUDE RECORDED FROM THE MACROELECTRODE CONTACT PAIRS DECREASED BY 47.9% FOR THE RIGHT STN, WHEREAS THE LEFT STN LFP AMPLITUDE REMAINED ALMOST UNCHANGED. IN BOTH RECORDING SESSIONS, SPECTRAL ACTIVITY FROM THE LEFT STN PEAKED AT AROUND 15HZ, WHEREAS RECORDINGS FROM THE RIGHT STN CONTAINED NO PEAKS. IN THE SECOND RECORDING SESSION, THE MEAN ELECTRODE IMPEDANCE FOR THE CONTACT PAIRS ALSO DECREASED FOR THE RIGHT SIDE (TO 3.40 K-OHMS) WHEREAS THEY REMAINED STABLE FOR THE LEFT SIDE (10.63 K-OHMS). ELECTRODE IMPEDANCE SIGNIFICANTLY CORRELATED WITH STN LFP AMPLITUDE VALUE. SEVEN DAYS AFTER DBS IMPLANTATION, IN THE AFTERNOON, THE PATIENT UNDERWENT SURGERY UNDER GENERAL ANESTHESIA TO INSERT THE HIGH-FREQUENCY STIMULATOR IN A SUBMUSCULAR POUCH UNDER THE PECTORALIS MAJOR MUSCLE. AFTER HOSPITAL DISCHARGE THE PATIENT STARTED A REHABILITATION PROGRAM. ONE MONTH LATER, THE PATIENT HAD FULLY RECOVERED FROM THE HEMIPARESIS. CT BRAIN SCAN NO LONGER SHOWED THE HEMORRHAGIC HYPERDENSITY OR THE HYPODENSITY IN THE MIDBRAIN, PONS, AND CEREBRAL PEDUNCLE, EVEN THOUGH NO ADDITIONAL TECHNIQUES TO DETECT ANY POSSIBLE RESIDUAL STRUCTURAL CHANGES WERE PERFORMED. THE REPORTER STATED THAT IT COULD BE HYPOTHESIZED THAT, IN THE EARLY STUNNING PHASE, NEURONAL APRAXIA IMPAIRED THE NEURONAL OSCILLATORY ACTIVITY THUS LEADING TO ABNORMAL LFP RECORDINGS. AFTERWARDS, BRAIN EDEMA AND BLEEDING ALTER ALSO TISSUE CONDUCTIVITY AND ULTIMATELY REDUCE IMPEDANCE. THE SOURCE LITERATURE DID NOT INCLUDE ANY SPECIFIC DEVICE INFORMATION. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385978 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