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Medtronic DBS - User Manual

Medtronic DBS
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Medtronic
®
DBS™ Therapy
Implanted neurostimulators
Thérapie DBS™ de Medtronic
®
Neurostimulateurs implantés
Medtronic
®
DBS™ Therapie
Implantierte Neurostimulatoren
Medtronic
®
DBS™-therapie
Geïmplanteerde neurostimulatoren
Terapia Medtronic
®
DBS™
Neurostimolatori impiantati
Θεραπεία DBS™ της Medtronic
®
Εμφυτευμένοι νευροδιεγέρτες
Information for prescribers • Informations pour les prescripteurs •
Informationen für verordnende Ärzte • Informatie voor voorschrijvend artsen
• Informazioni per i medici • Πληροφορίες για συνταγογραφούντες
  Rx only
Printing instructions: Refer to doc# A88898 for
Printing Instructions

Table of Contents

Questions and Answers

  • Т
    ТатьянаAug 6, 2026
    МОЖНО ЛИ ПРОВОДИТЬ ИМПЛАНТАЦИЮ ЗУБОВ ПРИ УСТАНОВЛЕННОМ MEDTRONIC DBS

    Summary

    Contraindications

    Diathermy

    Contraindicated for patients exposed to diathermy due to risk of tissue damage.

    Certain magnetic resonance imaging (MRI) procedures

    Contraindicated for specific DBS systems due to risk of tissue heating and severe injury.

    Unable to operate patient devices

    Contraindicated for patients unable to operate control or charging devices without assistance.

    Transcranial magnetic stimulation (TMS)

    Contraindicated for patients with an implanted DBS System.

    Warnings

    Avoid excessive stimulation

    Risk of brain tissue damage from high amplitude and wide pulse width settings.

    Case damage

    Rupture or piercing of neurostimulator case can cause severe burns from battery chemicals.

    Coagulopathies

    Extreme care needed during lead implantation in patients at heightened risk of intracranial hemorrhage.

    Electromagnetic interference (EMI)

    Field generated by equipment that can disrupt neurostimulator function, causing injury or system damage.

    Interaction with implanted cardiac devices

    Discuss possible interactions between neurostimulator and cardiac devices before surgery.

    Precautions

    Physician training

    Implanting and prescribing physicians need specific experience and knowledge of DBS procedures.

    Medical procedure coordination

    Decision to turn off neurostimulator for procedures needs careful consideration and consultation.

    Storage and sterilization

    Guidelines for component packaging, sterilization, and storage temperatures.

    System implant

    Compatibility, all components

    Guidelines for selecting compatible Medtronic or non-Medtronic components for implant or replacement.

    Explantation and EMI considerations

    Patients with partially explanted systems remain susceptible to EMI effects.

    Extension replacement and MRI considerations

    Evaluate MRI scan eligibility when selecting replacement components, considering extension type.

    Component failures

    The system may unexpectedly cease to function due to various events.

    Component handling

    Implantable components must be handled with extreme care to avoid damage.

    Extension routing for multiple leads

    Proper routing of lead-extensions minimizes EMI potential.

    Multiple implants

    Neurostimulator location

    Guidelines for selecting an optimal location for the neurostimulator.

    Device specific considerations

    Soletra Model 7426 and Kinetra Model 7428 neurostimulators

    Specific considerations for replacing or using these neurostimulator models.

    Activa RC Model 37612 Neurostimulator

    Specific considerations for the Activa RC neurostimulator.

    Importance of regular recharging (rechargeable neurostimulator only)

    Charging system (rechargeable neurostimulator only)

    Wound contact

    Do not use the recharger on an unhealed wound due to sterility issues.

    Low battery charge level

    Advise patients to charge regularly to prevent battery discharge and overdischarge.

    Clinician programming

    Effects on other medical devices

    DBS system may affect operation of other implanted devices like pacemakers.

    Parameter adjustment

    Lower amplitude to 0.0 V before connecting/disconnecting cables or replacing batteries.

    Programmer interaction with a cochlear implant

    Programmer interaction with flammable atmospheres

    Programmer interaction with other active implanted devices

    Screening with external neurostimulators

    Telemetry signal disruption from EMI

    Clinician information and general guidance

    Patient counseling information

    Advise patients on risks, benefits, and reading the patient manual.

    Patient selection (rechargeable neurostimulator only)

    Special consideration should be given to the following:

    Factors like caregiver support, age, mental/physical ability, and visual acuity are important.

    Patient information

    Programming and patient control devices

    Group selection, interaction with other devices, device handling, use, and recharger use.

    Patient activities

    Activities requiring coordination, excessive twisting/stretching, and component manipulation.

    Patient activities;environmental precautions

    Scuba diving or hyperbaric chambers

    Skydiving, skiing, or hiking in the mountains

    Hospital or medical environment

    Effect on electrocardiograms (ECGs)

    Ensure neurostimulator is programmed to 'Off' before ECG to avoid inaccurate results.

    Home or occupational environment

    Radio-frequency sources

    Keep RF devices at least 10 cm (4 in) away to prevent unintended stimulation changes.

    Adverse events

    Risks (potential adverse events) related to the lead, extension, or neurostimulator implant, explant, or revision procedures

    Potential risks including intracranial hemorrhage, anesthesia complications, and procedure-related issues.

    Risks (potential adverse events) after implantation of the lead(s), extension(s), or neurostimulator(s)

    Potential risks including delayed hemorrhage, site complications, infection, and neurological symptoms.

    Component disposal

    Appendix A: Electromagnetic interference (EMI) and mechanical interference

    Types of electromagnetic interference (EMI)

    Describes three types of EMI: conductive current, induced/coupled current, and radiated energy.

    Reducing the possible effects from EMI

    EMI guidelines for medical procedures

    Turning the neurostimulator off

    MR MR Conditional

    Computed tomography (CT) scan

    Diathermy

    Electrocautery

    Laser procedures

    Additional EMI source examples: Conductive

    Bone growth stimulators

    Safety not established for use with implanted DBS systems.

    External defibrillators

    Safety not established; external defibrillation may damage system or cause tissue damage.

    Radio-frequency or microwave ablation

    Safety not established; induced currents may cause heating and tissue damage.

    Recording procedures

    Safety not established for recording procedures using EMI-generating equipment.

    Transcutaneous electrical nerve stimulation (TENS)

    Place TENS electrodes to avoid passing current over system components.

    Additional EMI source examples: Inductive

    Therapeutic magnets

    Magnets can cause inadvertent on/off activation of neurostimulator; advise patients not to use them.

    Theft detectors and security screening devices

    Advise patients to approach security devices with caution as they can turn neurostimulator on/off.

    Additional EMI source examples: Conductive and inductive

    Additional EMI source examples: Radiation

    Mechanical interference

    Diagnostic ultrasound

    No electrical interference issues, but transducer should not be placed directly over the implant.

    Lithotripsy

    Use of high-output ultrasonic devices is not recommended due to potential damage to neurostimulator circuitry.

    Medtronic DBS Specifications

    General IconGeneral
    ManufacturerMedtronic
    Device TypeDeep Brain Stimulation System
    Intended UseTreatment of movement disorders such as Parkinson's disease, essential tremor, and dystonia
    ComponentsPulse generator, leads, extensions, and programmer
    Battery LifeVaries by model and usage, typically 3-5 years for non-rechargeable, up to 9 years for rechargeable
    IndicationParkinson's disease, essential tremor, dystonia
    Target Brain RegionSubthalamic nucleus (STN), globus pallidus internus (GPi), thalamus (Vim)
    Pulse Generator TypeRechargeable and non-rechargeable options available.
    MRI CompatibilityConditional, specific models may be MRI-compatible under certain conditions
    Lead ConfigurationQuadripolar or octopolar leads

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