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
General Warnings
General Warning
Medtronic implantable pacemakers and leads are implanted in the
extremely hostile environment of the human body. This environment places
severe limitations on the design and function of the pacemaker and lead.
These limitations unavoidably reduce the potential performance and
longevity of the pacemaker and lead despite the exercise of due care in
design, component selection, manufacture and testing prior to sale.
Reference is hereby made to published data on predictable failure rates of
the pacemaker and lead and their implantation which have either been
furnished by Medtronic or are otherwise available to physicians. The
pacemaker includes a nonseparable power source which will ultimately
cease to function due to exhaustion or premature failure thereby
necessitating removal of the pacemaker. The lead is necessarily very small
in diameter and very flexible, which unavoidably increases the likelihood
of breakage or breach of its insulation. Other reasons for failure of the
pacemaker or lead include, but are not limited to: body rejection
phenomena; change in performance characteristics due to component
changes or failures; unusual physiological variations in patients; medical
complications; lead displacement; lead fracture; fibrotic tissue formation;
erosion of the pacemaker or lead through body tissue or interference from
transmitters, tools, appliances, instruments, equipment or other devices
which use electricity or electromagnetic wave transmission. Consequently,
no representation or warranty is made that failure or cessation of function
of the pacemaker or lead will not occur, that the body will not react
adversely to the implantation of the pacemaker or lead, that medical
complications will not follow the implantation of the pacemaker or lead or
that the pacemaker and lead will, in all cases, restore adequate cardiac
function.
Side Effects
Possible side effects include, but are not limited to, body rejection
phenomena including local tissue reaction, muscle and nerve stimulation,
infection, erosion of pacemaker lead through skin, transvenous lead-related
thrombosis, embolism and cardiac tamponade.
F-2 Prodigy Reference Information
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