BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4631161 · Received March 25, 2015

    Report

    Report Number
    3007566237-2015-00722
    Event Type
    Injury
    Date Received
    March 25, 2015
    Date of Event
    January 21, 2015
    Report Date
    February 26, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    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 PRODUCTS: PRODUCT ID: 3387 LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (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)-YEAR-OLD FEMALE PATIENT UNDERWENT BILATERAL SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) TO TREAT ESSENTIAL TREMOR WITH TREMULOUS PARKINSONIAN FEATURES. FOLLOWING STN DBS, THERE WAS SIGNIFICANT IMPROVEMENT IN PARKISONIAN CONTROL, PARTICULARLY TREMOR. HOWEVER, DESPITE APPROPRIATE POSITIONING OF LEADS AND SUPPRESSION OF TREMOR, SHE DEVELOPED PERSISTENT DISABLING AND PAINFUL LOWER LIMB DYSKINESIAS IN THE WEEKS FOLLOWING THE SURGERY. THE PATIENT¿S DYSKINESIAS WORSENED, INCREASING IN DURATION FROM 26-50% OF HER WAKING TIME TO 51-75% OF HER WAKING TIME, AND GRADING TO COMPLETELY DISABLING AND MARKEDLY PAINFUL. THESE COULD NOT BE CONTROLLED BY ADJUSTING STIMULATION PARAMETERS WITHOUT LOSING STIMULATION-RELATED TREMOR CONTROL. WITH STN STIMULATION SET TO OFF, DYSKINESIAS WERE STILL DISABLING. A VARIETY OF MEDICATION COMBINATIONS WERE TRIALED, INCLUDING L-DOPA/CARBIDOPA, AMANTADINE, APOMORPHINE, CLONAZEPAM, AND LEVETIRACETAM. NONE WERE EFFECTIVE AND THE PATIENT BECAME WHEELCHAIR-DEPENDENT DUE TO PERSISTENT LOWER LIMB DYSKINESIAS. ONE YEAR FOLLOWING STN-DBS, THE PATIENT ELECTED TO UNDERGO ADDITIONAL BILATERAL GLOBUS PALLIDUS INTERNUS (GPI) DBS IMPLANT. FOLLOWING GPI DBS, THE DYSKINESIAS WERE SUPPRESSED AND HER MOBILITY RESTORED. DYSKINESIAS RETURNED WHEN GPI STIMULATION WAS TURNED OFF. THE PATIENT¿S UNIFIED PARKINSON¿S DISEASE RATING SCALE (UPDRS)-III SCORES WERE 47 (ON MEDICATION, ON STN, OFF GPI) AND 25 (ON MEDICATION, ON STN, ON GPI). ONGOING STN STIMULATION WAS REQUIRED TO ACHIEVE TREMOR SUPPRESSION. THE REPORTER STATED THAT GIVEN THE RAPIDITY WITH WHICH DYSKINESIA DEVELOPED AFTER SURGERY, IT WAS ASSUMED THAT THIS WAS AN EFFECT OF BILATERAL SUBTHALAMOTOMY; THE PATIENT¿S SMALL BRAIN, TOGETHER WITH THE RELATIVELY LONG STN PASSES AND THE STANDARD TECHNIQUE OF USING A 1.8MM THERMISTOR ROD TO CREATE THE TRACK FOR THE DBS ELECTRODE PRIOR TO IMPLANTATION OF THE PERMANENT STIMULATING ELECTRODE, MAY HAVE BEEN CONTRIBUTING FACTORS. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: LEAD MODEL 3387 AND EITHER 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
    199856 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention