Specifications

7 x 9 inches (178 mm x 229 mm)
Medtronic Confidential
Refer to the “Reference man.” category in doc#163256 for Printing
Instructions.
196407001 Rev A
Potential Effects of Pressure on the
Pacemaker
Clinical studies of activity rate responsive pacemakers have reported
instances of increased sensitivity to muscle motion (such as heart
contractions) when external pressure is exerted on the device. This
increased sensitivity to muscle motion can potentially cause an increase
in the pacing rate up to the programmed Upper Activity Rate. This
might occur when the patient is lying on the pacemaker while sleeping,
or by pressing the programmer head over the pacemaker.
Implantation of the pacemaker near the patient’s skeletal system (e.g., in a
very thin patient), may augment the effect when pressure is applied. During
such occurrences, the Prodigy pacemaker is operating as it was designed.
This phenomenon does not indicate device malfunction or inappropriate
programming. Relieving the abnormal pressure on the device will restore
the appropriate pacing rate. Reprogramming the Activity Threshold to
Medium High or High has been shown to resolve the situation if the
patient’s observed rate response is not significantly effected.
Muscle Stimulation with Unipolar Pacing
■
Prodigy DR Under certain circumstances (e.g.,
(Model 7861) high output settings, etc.) these
Prodigy D (Model 7865) unipolar-only pacemakers may
Prodigy SR (Model 8161) induce muscle stimulation at the
Prodigy S (Model 8165) pocket site.
■
Prodigy DR These bipolar Prodigy pacemaker models
(Models 7860, 7862) programmed to unipolar pacing may
Prodigy D exhibit muscle stimulation also.
(Models 7864, 7866)
Prodigy VDD (Model 8168)
Prodigy SR
(Models 8158, 8160, 8162)
Prodigy S
(Models 8164, 8166)
Such stimulation may reach and be limited to rates of 80 or 90 ppm when
the programmed Upper Activity Rate is 80 or 90 ppm. At programmed
Upper Activity Rates greater than 100 ppm, rate elevation due to
pacemaker-induced muscle stimulation may reach a maximum of 95 ppm.
Pacemaker-induced muscle stimulation may be effectively controlled
and/or eliminated by programming Pulse Width to a narrower setting or
programming a lower Amplitude.
Warnings and Precautions F-7
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