BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4628684 · Received March 24, 2015

    Report

    Report Number
    3007566237-2015-00708
    Event Type
    Injury
    Date Received
    March 24, 2015
    Date of Event
    June 21, 2014
    Report Date
    February 26, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: 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 3387, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID 3387, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    COOK, R.J., JONES, L., FRACCHIA, G., ANDERSON, N., MIU, J., MEAGHER, L. J., SILBURN, P.A., SILBERSTEIN, P. GLOBUS PALLIDUS INTERNUS DEEP BRAIN STIMULATION AS RESCUE THERAPY FOR REFRACTORY DYSKINESIAS FOLLOWING EFFECTIVE SUBTHALAMIC NUCLEUS STIMULATION. STEREOTACTIC AND FUNCTIONAL NEUROSURGERY. 2015;93(1):25-29. DOI: 10.1159/000365223. SUMMARY: DEEP BRAIN STIMULATION (DBS) AT THE SUBTHALAMIC NUCLEUS (STN) OR GLOBUS PALLIDUS INTERNUS (GPI) CAN EFFECTIVELY TREAT THE MOTOR SYMPTOMS OF PARKINSON¿S DISEASE, BUT DUAL IMPLANTATION IS RARE. WE REPORT THE FIRST CASES OF ADDITIONAL GPI STIMULATION AS RESCUE THERAPY FOR DISABLING DYSKINESIAS FOLLOWING SUCCESSFUL STN STIMULATION. TWO PATIENTS, INITIALLY TREATED WITH BILATERAL STN DBS, UNDERWENT SUBSEQUENT BILATERAL GPI DBS AFTER THE DEVELOPMENT OF REFRACTORY DYSKINESIAS WITHIN 1 AND 6 YEARS OF STN SURGERY. PATIENTS WERE EVALUATED WITH THE UNIFIED PARKINSON¿S DISEASE RATING SCALE (UPDRS) BEFORE AND AFTER SURGERIES FOR STN AND GPI DBS. GPI DBS EFFECTIVELY SUPPRESSED DYSKINESIAS IN THESE PATIENTS AND IMPROVED THEIR QUALITY OF LIFE, AS DEMONSTRATED BY THEIR VIDEOS AND UPDRS SCORES. ADDITIONAL BILATERAL GPI DBS MAY BE CONSIDERED IN THE RARE INSTANCE OF PATIENTS WHO DEVELOP REFRACTORY DYSKINESIAS EARLY OR LATE AFTER BILATERAL STN DBS. REPORTED EVENT: ONE (B)(6) MALE PATIENT UNDERWENT BILATERAL SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) FOR YOUNG-ONSET PARKINSONIAN SYNDROME WITH SYMPTOMATIC IMPROVEMENT. MOTOR FLUCTUATIONS AND DYSKINESIAS RETURNED OVER THE NEXT TWO YEARS. THESE INITIALLY IMPROVED WITH ADJUSTMENTS IN STIMULATION PARAMETERS AND THE INTRODUCTION OF INTERMITTENT APOMORPHINE, BUT WITH PROGRESSIVE LOSS OF SYMPTOMATIC CONTROL, LEAD POSITION WAS RE-EVALUATED AND THE PATIENT UNDERWENT REPOSITIONING OF THE STN LEADS. THE PATIENT IMPROVED TO THE EXTENT THAT ALL PARKINSON¿S DISEASE MEDICATIONS CEASED. WORSENING PARKINSONISM NECESSITATED THE RE-INTRODUCTION OF DOPAMINERGIC MEDICATION AFTER 1.5 YEARS. A RANGE OF MEDICATIONS WERE TRIALED, INCLUDING COMBINATIONS OF L-DOPA, ENTACAPONE, AMANTADINE, AND PRAMIPEXOLE. WHILST INITIALLY EFFECTIVE, THERE WAS A GRADUAL NARROWING OF THE THERAPEUTIC WINDOW WITH THE RE-EMERGENCE OF MOTOR FLUCTUATIONS AND DYSKINESIAS, AND THE PATIENT ULTIMATELY ELECTRODE FOR ADDITIONAL BILATERAL GLOBUS PALLIDUS INTERNUS (GPI) DBS, 5.5 YEARS AFTER STN LEAD REPOSITIONING. PRIOR TO GPI SURGERY, SYMPTOMATIC OFF TIME WAS REPORTED AS 26-50% AND DYSKINESIAS 51-75% OF HIS WAKING TIME. DYSKINESIAS WERE SCORED AS SEVERELY DISABLING AND MODERATELY PAINFUL, WITH LEFT FOOT DYSTONIA BEING HIS MAJOR OFF SYMPTOM. GPI DBS LED TO IMPROVED DYSKINESIA CONTROL AND FACILITATED AN INCREASE IN DOPAMINERGIC MEDICATION, IN TOTAL RESULTING IN A REDUCTION IN THE SEVERITY OF OFF-MEDICATION SEVERITY. GPI STIMULATION WITHOUT STN ACTIVATION WAS NOT EFFECTIVE IN PROVIDING RELIEF OF CARDINAL PARKINSONIAN FEATURES, NECESSITATING ACTIVATION OF BOTH SYSTEMS FOR OPTIMAL SYMPTOM CONTROL. UNIFIED PARKINSON¿S DISEASE RATING SCALE (UPDRS)-III SCORE WAS 33. THE PATIENT EXPERIENCED SEVERE DYSKINESIA WHEN GPI DBS WAS OFF. THE REPORTER STATED THAT THE DYSKINESIAS LIKELY RECURRED DUE TO A FURTHER NARROWING OF THE THERAPEUTIC WINDOW, WHICH LED TO THE CONSIDERATION OF STN DBS IN THE INITIAL INSTANCE. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: LEAD MODEL 3387 AND KINETRA, ACTIVA RC, OR ACTIVA PC IMPLANTABLE NEUROSTIMULATORS 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
    195454 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00026 YR Required Intervention