Warnings - Medtronic DBS Informationen Für Verordnende Ärzte

Warnings

Avoid excessive stimulation - There is a potential risk of brain tissue damage from high
amplitude and wide pulse width parameter settings.
Programming at high amplitudes and wide pulse widths should only be done with due
consideration of the charge density warning described in the software programming
guide.
The Medtronic DBS System can be programmed to use parameter settings outside the
range of those used in the clinical studies. If the programming of stimulation parameters
exceeds charge density limits, the following programmer warning appears: WARNING:
CHARGE DENSITY MAY BE HIGH ENOUGH TO CAUSE TISSUE DAMAGE.
Note: Higher amplitudes and wider pulse widths may indicate a system problem or a less
than optimal lead placement.
Case damage - If the neurostimulator case is ruptured or pierced due to outside forces,
severe burns could result from exposure to the battery chemicals.
Coagulopathies - Use extreme care with lead implantation in patients with a heightened
risk of intracranial hemorrhage. Physicians should consider underlying factors, such as
previous neurological injury, or prescribed medications (anticoagulants) that may
predispose a patient to the risk of bleeding.
Electromagnetic interference (EMI) - Electromagnetic interference is a field of energy
generated by equipment found in the home, work, medical, or public environments that is
strong enough to interfere with neurostimulator function. Neurostimulators include
features that provide protection from electromagnetic interference. Most electrical devices
and magnets encountered in a normal day are unlikely to affect the operation of a
neurostimulator. However, sources of strong electromagnetic interference can result in
the following effects:
▪
Serious patient injury or death—it is possible for the extension, lead, or both to
"pick up" electromagnetic interference and deliver an excess current causing tissue
damage, including brain tissue damage.
▪
System damage—resulting in a loss of or change in symptom control and requiring
surgical replacement.
▪
Operational changes to the neurostimulator—causing it to turn on or off, or to
reset to power-on-reset (POR) settings, resulting in loss of stimulation, return of
symptoms, and in the case of a POR, may require reprogramming by a clinician.
▪
Unexpected changes in stimulation—causing a momentary increase in stimulation
or intermittent stimulation, which some patients have described as jolting or shocking.
Refer to "Appendix A: Electromagnetic interference (EMI) and mechanical
interference" on page 20 for guidelines on medical procedures that generate EMI
and the possible adverse effects of EMI on an implanted DBS system.
Interaction with implanted cardiac devices - When a patient's medical condition
requires both a neurostimulator and an implanted cardiac device (eg, pacemaker,
defibrillator), physicians involved with both devices (eg, neurologist, neurosurgeon,
cardiologist, cardiac surgeon) should discuss the possible interactions between the
devices before surgery.
6 English Information for prescribers 2017-05-01