BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3202457 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-02183
    Event Type
    Death
    Date Received
    July 2, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL DATE OF DEATH WAS NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CONCOMITANT PRODUCTS: PRODUCT ID NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387-40, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387-40, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    LI, D., CAO, C., ZHANG, J., ZHAN, S., CHEN, S., SUN, B. SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION FOR PARKINSON'S DISEASE: 8 YEARSOF FOLLOW-UP. TRANSLATIONAL NEURODEGENERATION. 2013;2(1):11. DOI: 10.1186/2047-9158-2-11. SUMMARY: THE SHORT-TERM BENEFITS OF BILATERAL STIMULATION OF THE SUBTHALAMIC NUCLEUS (STN) IN PATIENTS WITH ADVANCED PARKINSON¿S DISEASE (PD) ARE WELL DOCUMENTED, BUT LONG-TERM BENEFITS ARE STILL UNCERTAIN. THE AIM OF THIS STUDY IS TO EVALUATE THE OUTCOME OF 8 YEARS OF BILATERAL STN STIMULATION TO PD PATIENTS. IN THIS STUDY, 31 CONSECUTIVE PD PATIENTS WERE TREATED WITH BILATERAL STN STIMULATION. THEIR FUNCTIONAL STATUS WAS MEASURED USING THE ACTIVITIES OF DAILY LIVING SECTION OF THE UNIFIED PARKINSON¿S DISEASE RATING SCALE (UPDRS-ADL) AT DRUG ON (WITH MEDICATION) AND DRUG OFF (WITHOUT MEDICATION) STATES PREOPERATIVELY AND AT 1, 5, AND 8 YEARS POSTOPERATIVELY. IN ADDITION, LEVODOPA EQUIVALENT DOSES AND STIMULATION PARAMETERS WERE ALSO ASSESSED. AFTER 8 YEARS OF STN STIMULATION, THE UPDRS-ADL SCORES WERE IMPROVED BY 4% AT DRUG OFF STATUS (P > 0.05) AND 22% AT DRUG ON STATUS (P <(><<)> 0.05) COMPARED WITH BASELINE; THE LEVODOPA DAILY DOSES WERE REDUCED BY 28% = (P <(><<)> 0.05) COMPARED WITH BASELINE; THE STIMULATION VOLTAGE AND PULSE WIDTH W ERE NOT CHANGED, BUT THE STIMULATION FREQUENCY WAS DECREASED REMARKABLY COMPARED WITH THE 5 YEARS OF FOLLOW-UP. ADVERSE EVENTS WERE OBSERVED IN 6 PATIENTS, INCLUDING MISPLACEMENT OF THE ELECTRODE AND SKIN EROSION REQUIRING FURTHER SURGERY. ALL EVENTS WERE RESOLVED WITHOUT PERMANENT SEQUELAE. 2 PATIENTS DIED OF ASPIRATION PNEUMONIA 6 AND 7 YEARS AFTER SURGERY. THE MARKED IMPROVEMENT IN UPDRS-ADL SCORES WERE STILL OBSERVED AFTER 8 YEARS OF BILATERAL STN STIMULATION WITH MEDICATION. REPORTED EVENTS: TWO PATIENTS HAD SKIN EROSION IN POCKET SITE. THE STIMULATORS WERE REPOSITIONED. ALL EVENTS WERE RESOLVED WITHOUT PERMANENT SEQUELAE. FOUR PATIENTS HAD MALPOSITION OF THE ELECTRODES, WHICH WAS REVEALED BY INEFFECTIVENESS OF STIMULATION AND MRI. THE ELECTRODES WERE ADJUSTED TO ALLEVIATE THE SYMPTOMS. ALL EVENTS WERE RESOLVED WITHOUT PERMANENT SEQUELAE. ONE PATIENT DIED OF ASPIRATION PNEUMONIA DUE TO SWALLOW DISORDERS 6 YEARS AFTER SURGERY. ONE PATIENT DIED OF ASPIRATION PNEUMONIA DUE TO SWALLOW DISORDERS 7 YEARS AFTER SURGERY. UNIDENTIFIED NUMBER OF PATIENTS DEVELOPED AXIAL SYMPTOMS SUCHAS SWALLOW, SPEECH AND GAIT DISORDERS. AS A RESULT, THE STIMULATION WAS REDUCED FURTHER TO IMPROVE BALANCE AND SPEECH FUNCTIONS, ESPECIALLY IN SOME BRADYKINESIA OR RIGIDITY DOMINATED PATIENTS. 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
    302540 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death