8
Single use only
The device and screwdriver are intended for single use only.
• Do not use the device if the package is damaged.
• The device must not be resterilized and reused.
Possible Complications
General information on medical complications
Complications for patients and device systems generally recognized among practitio-
ners also apply to BIOTRONIK devices.
• Normal complications may include fluid accumulation within the device pocket,
infections, or tissue reactions. Primary sources of complication information include
current scientific and technological knowledge.
• It is not possible to guarantee the efficacy of antitachycardia therapy, even if the
programs have proven successful during tests or subsequent electrophysiological
examinations. In rare cases the set parameters may become ineffective. In partic-
ular it is inevitable that tachyarrhythmias may be induced.
Skeletal myopotentials
Bipolar sensing and control of sensitivity are adapted by the device to the rate range of
intrinsic events so that skeletal myopotentials are usually not sensed. Skeletal myopo-
tentials can nonetheless be classified as intrinsic events especially with a unipolar
configuration and/or very high sensitivity and, depending on the interference, may
cause inhibition or antiarrhythmia therapy.
Nerve and muscle stimulation
A device system consisting of a unipolar lead and an uncoated device may result in
undesirable pacing of the diaphragm in the case of an initial or permanent high setting
of the pulse amplitude.
Possible technical failures
Technical failure of a device system cannot be entirely ruled out. Possible causes may
include the following:
• Lead dislodgement
• Lead fracture
• Insulation defects
• Device component failures
• Battery depletion
Electromagnetic interference (EMI)
Any device can be sensitive to interference, for example, when external signals are
sensed as intrinsic rhythm or if measurements prevent rate adaptation.
• BIOTRONIK devices have been designed so that their susceptibility to EMI is
minimal.
• Due to the intensity and variety of EMI, there is no guarantee for safety. It is
generally assumed that EMI produces only minor symptoms in patients - if any.
• Depending on the pacing mode and the type of interference, sources of interference
may lead to pulse inhibition or triggering, an increase in the sensor-dependent
pacing rate or asynchronous pacing.
• Under unfavorable conditions, for example during diagnostic or therapeutic proce-
dures, interference sources may induce such a high level of energy into the pacing
system that the cardiac tissue surrounding the lead tip is damaged.
Device behavior in case of EMI
In the case of electromagnetic interference or undesired myopotentials, the device
switches to asynchronous pacing for the duration of the time that the interference rate
is exceeded.
Static magnetic fields
The reed switch in the pacemaker starts to close at a field strength of 1.5 mT.
Possible Risks
Procedures to avoid
The following procedures must be avoided as they may cause harm to the patient or
damage the device and, as a result, put the system functionality at risk:
• Therapeutic ultrasound
• Transcutaneous electrical nerve stimulation
• Hyperbaric oxygen therapy
• Applied pressures higher than normal pressure
Potentially risky therapeutic and diagnostic procedures
If electrical current from an external source is conducted through the body for diag-
nostic or therapeutic purposes, then the device can be subjected to interference and
the patient placed at risk.
401303--G_GA_Eluna-I-ProMRI_mul.book Page 8 Friday, October 2, 2015 4:57 PM
