System Implant - Medtronic DBS Informationen Für Verordnende Ärzte

System implant

Compatibility, all components - Follow these guidelines when selecting system
components for either initial implant or replacement:
▪
Medtronic components: For proper therapy, use only Medtronic Neuromodulation
components that are compatible or specified in an intended use statement (if
present). For each product, refer to the indication insert(s) and shipping label for this
information.
Components are compatible when the following conditions are met:
– Components have the same indication.
– For implanted components, the contact spacing and the number of electrode
contacts at the connections for the lead and extension/neurostimulator or
extension and neurostimulator are the same.
▪
Non-Medtronic components: No claims of safety or efficacy are made with regard
to the compatibility of using non-Medtronic components with Medtronic components.
Refer to the non-Medtronic documentation for information.
Explantation and EMI considerations - If any DBS System components
(neurostimulator, lead, extension, or lead-extension fragment) remain implanted in the
patient's body after a partial system explant, the patient is still susceptible to possible
adverse effects from EMI. These effects include induced current and component heating,
which may result in shocking or jolting the patient and tissue damage resulting in serious
injury or death. Advise patients who have any DBS System components implanted in their
body to notify all medical personnel that they have an implanted DBS System.
Extension replacement and MRI considerations - Evaluate MRI scan eligibility when
selecting system components for replacement. To facilitate full-body MRI scan eligibility,
consider replacing a two-pronged quadripolar extension with an in-line extension instead
of implanting a pocket adaptor during neurostimulator revision surgery. MRI using a full
body transmit radio-frequency (RF) coil, a receive-only head coil, or a head transmit coil
that extends over the chest area is contraindicated for patients implanted with a pocket
adaptor.
Component failures - The DBS System may unexpectedly cease to function due to
certain events. These events, which can include electrical short or open circuits,
conductor wire fracture, and insulation breaches, cannot be predicted. The patient's
disease symptoms will return if the device ceases to function.
Component handling - Handle the implantable components of this system with extreme
care. These components may be damaged by excessive traction or sharp instruments,
which may result in intermittent or loss of stimulation, requiring surgical replacement.
Refer to the appropriate implant manual for additional instructions.
Extension routing for multiple leads - When multiple leads are implanted, route the
lead-extensions so the area between them is minimized (Figure 1). If the lead-extensions
are routed in a loop, the loop will increase the potential for electromagnetic interference
(EMI).
Information for prescribers 2017-05-01 English 9