BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4323310 · Received December 11, 2014

    Report

    Report Number
    3007566237-2014-03596
    Event Type
    Injury
    Date Received
    December 11, 2014
    Report Date
    November 20, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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 INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CHAN, A.Y., YEUNG, J.H., MOK, V.C., IP, V., WONG, A., KUO, S.H., CHAN, D., ZHU, X.L., WONG, E., LAU, C., WONG, R., TANG, V., LAU, C., POON, W.S. SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION FOR PARKINSON'S DISEASE: EVIDENCE FOR EFFECTIVENESS AND LIMITATIONS FROM 12 YEARS' EXPERIENCE. HONG KONG MEDICAL JOURNAL = XIANGGANG YI XUE ZA ZHI / HONG KONG ACADEMY OF MEDICINE. 2014. DOI: 10.12809/HKMJ144242. SUMMARY: A COHORT OF PATIENTS WITH PARKINSON¿S DISEASE RECEIVED SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION FROM SEPTEMBER 1998 TO JANUARY 2010. PATIENT ASSESSMENT DATA BEFORE AND AFTER THE OPERATION WERE COLLECTED PROSPECTIVELY. FORTY-ONE PATIENTS (21 MALE AND 20 FEMALE) WITH PARKINSON¿S DISEASE UNDERWENT BILATERAL SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION AND WERE FOLLOWED FOR A MEDIAN INTERVAL OF 12 MONTHS. FOR THE WHOLE GROUP, THE MEAN IMPROVEMENTS OF UNIFIED PARKINSON¿S DISEASE RATING SCALE (UPDRS) PARTS II AND III WERE 32.5% AND 31.5%, RESPECTIVELY (P<(><<)>0.001). THROUGHOUT THE YEARS, A MULTIDISCIPLINARY TEAM WAS GRADUALLY BUILT. THE DEEP BRAIN STIMULATION PROTOCOL EVOLVED AND WAS SUBSTANTIATED BY UPDATED PATIENT SELECTION CRITERIA AND OUTCOME ASSESSMENT, INTEGRATED IMAGING AND NEUROPHYSIOLOGICAL TARGETING, REFINEMENT OF SURGICAL TECHNIQUE AS WELL AS THE ACCUMULATION OF EXPERIENCE IN DEEP BRAIN STIMULATION PROGRAMMING. MOST OF THE STRUCTURAL IMPROVEMENT OCCURRED BEFORE MID-2005. PATIENTS RECEIVING THE OPERATION BEFORE JUNE 2005 (19 CASES) AND AFTER (22 CASES) WERE COMPARED. THE IMPROVEMENTS IN UPDRS PART III WERE 13.2% AND 55.2%, RESPECTIVELY (P<(><<)>0.001). THERE WERE THREE OPERATIVE COMPLICATIONS (ONE LEAD MIGRATION, ONE CEREBRAL HAEMATOMA, AND ONE INFECTION) IN THE GROUP OPERATED BEFORE 2005. THERE WAS NO OPERATIVE MORTALITY. THE FUNCTIONAL STATE OF PARKINSON¿S DISEASE PATIENTS WITH MOTOR DISABILITIES REFRACTORY TO BEST MEDICAL TREATMENT IMPROVED SIGNIFICANTLY AFTER SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION. A DEDICATED MULTIDISCIPLINARY TEAM BUILDING, REFINED PROTOCOL FOR PATIENT SELECTION AND ASSESSMENT, IMPROVEMENT OF TARGETING METHODS, METICULOUS SURGICAL TECHNIQUE, AND EXPERIENCE IN PROGRAMMING ARE THE KEY FACTORS CONTRIBUTING TO THE IMPROVED OUTCOME. REPORTED EVENTS: 1. ONE PATIENT WITH DEEP BRAIN STIMULATION (DBS) FOR PARKINSON¿S DISEASE EXPERIENCED CEREBRAL HEMATOMA IN 2001. THE PATIENT REPORTEDLY BECAME DROWSY DURING THE OPERATION. THE SURGERY WAS STOPPED AND CT BRAIN REVEALED A SUBCORTICAL HEMATOMA LIKELY RELATED TO VENOUS INFARCTION. CRANIOTOMY FOR HEMATOMA EVACUATION WAS PERFORMED. THE PATIENT RECOVERED BUT WITH RESIDUAL HEMIPARESIS. 2. ONE PATIENT WITH DEEP BRAIN STIMULATION (DBS) FOR PARKINSON¿S DISEASE EXPERIENCED LEAD MIGRATION IN 2001, THREE MONTHS AFTER IMPLANT. THE PATIENT COMPLAINED OF INCREASED PARKINSON¿S DISEASE SYMPTOMS AFTER A FALL ON LEVEL GROUND. ONE DBS LEAD WAS FOUND WITHDRAWN FROM THE TARGET. IT WAS STATED TO BE RELATED TO THE INSECURITY OF LEAD FIXATION. IT WAS NOTED THAT A REVISION OPERATION WAS DONE WITH GOOD RECOVERY. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: IMPLANTABLE NEUROSTIMULATOR ITREL II MODEL 7424, SOLETRA MODEL 7426, OR KINETRA MODEL 7428 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
    804243 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention