OSYPKA PACE 203H, Instructions For Use Manual

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PACE 203H – Instructions for Use
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Complication Result
Inappropriately high sensitivity
setting. Sensing of R or T waves
in the atrium or P waves in the
ventricle. Detection of interfer-
ence (noise, electromagnetic
interference). Ventricular tachycardia, ventricular fibrillation, and
death, if not recognized immediately.
Time mismatch between
intracardiac conduction and
pacemaker settings. Pacemaker mediated tachycardia.
(In order to prevent this, some decision overrides are
implemented in PACE 203H. However, it is not pos-
sible to completely prevent the possibility of a pace-
maker mediated tachycardia.)
Overdrive stimulation in the atri-
um = rapid atrial pacing Accidental conduction into the ventricle can create
ventricular arrhythmia
Battery failure or exhaustion Failure of impulse emission. Failure to stimulate.
Technical defect in the
PACE 203H (failure of compo-
nents) Failure or change in the impulse emission, changed
(or no) sensing, incorrect displays. Failure to stimu-
late.
Undetected programming errors Chaotic rhythm
Erroneous lead connection Device does not function properly. Chaotic rhythm.
Failure to stimulate as intended.
Influence of defibrillation and RF
surgery. See chapter 8 for the effects while simultaneous use
of PACE 203H with defibrillators or electro-surgical
instruments.
Table 1: Possible Complications