387158--G_GA_Lumax540_mul.book Page 11 Friday, February 1, 2013 5:38 PM
• Embolism
• Increase in pacing threshold
• Detection failures
• Foreign body rejection
• Cardiac tamponade
• Muscle or nerve stimulation
• Device-induced arrhythmias
• Perforation of device pockets
• Infections
• Psychological intolerance or psychological dependency
Actions to prevent device-induced complications
W CAUTION
Transmission of atrial tachycardia to the ventricle
Set the following parameters to avoid unphysiological pacing in the ventricle in cases
of high atrial rates or sinus tachycardia:
• Activate Mode Switching for indicated patients.
• Set the upper rate and the refractory periods to prevent abrupt ventricular rate
switching.
• Prefer Wenckebach response and avoid 2:1 behavior.
Set all parameters to prevent constant switching between atrial and ventricle con-
trolled modes to prevent unphysiological rhythm switching upon loss of AV sequential
pacing.
W CAUTION
Pacemaker-mediated tachycardia in cases of retrograde conduction
Pacemaker-mediated tachycardia can occur in patients with retrograde conduction.
• Measure the retrograde conduction time.
• Switch on PMT protection to prevent pacemaker-mediated tachycardia.
• Set the VA criterion.
Skeletal myopotentials
Bipolar sensing and control of sensitivity are adapted by the device to the rate spectrum
of intrinsic events so that skeletal myopotenials are usually not detected. Skeletal myo-
potentials can very rarely be sensed as intrinsic events and, depending on the inter-
ference pattern, may provoke inhibition or antiarrhythmia therapy.
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Risky Therapeutic and Diagnostic Procedures
External defibrillation
The device is protected against the energy that is normally induced by external defibril-
lation. Nevertheless, any implanted device may be damaged by external defibrillation.
Specifically, the current induced in the implanted leads may result in necrotic tissue
formation close to the electrode/tissue interface. As a result, sensing properties and
pacing thresholds may change.
Note: Place adhesive electrodes anterior-posterior or perpendicular to the axis
formed by the device to the heart at least 10 cm away from the device and from
implanted leads.
Due to possible damage to the patient or the device, the use of the following procedures
is contraindicated:
• Therapeutic ultrasound and diathermy
— Damage to the patient via excess warming of body tissue near the device
• Radiation therapy
— Shield the device sufficiently against radiation.
— Check the system for integrity after applying radiation.
— Radiation can cause latent damage.
• Transcutaneous Electrical Nerve Stimulation (TENS)
• Lithotripsy
• Magnetic resonance imaging and the associated magnetic flux density
— Damage or destruction of the device system due to strong magnetic interaction
— Damage to the patient via excess warming of body tissue near the device
• Electrocautery and high-frequency surgery
— Damage to the patient via the induction of arrhythmia or ventricular fibrillation
• Hyperbaric oxygen therapy
• Applied pressures higher than normal pressure
W CAUTION
Interference with the device and risk to the patient due to electrical current during
medical treatment
If electrical current from an external source is conducted through the body for diag-
nostic or therapeutic purposes, then the device has to be switched off or carefully
monitored during the initial treatment phases.
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