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Chapter 12 Explantation
Evia HF / HF-T Technical Manual
PAGE 113
12. Explantation
Explanted pulse generators or explanted accessories may not be reused. Explanted pulse generators
can be sent either to the local BIOTRONIK representative or the BIOTRONIK home office for expert
disposal. If possible, the explanted pulse generator should be cleaned with a sodium-hyperchlorine
solution of at least 1% chlorine and, thereafter, washed with water prior to shipping.
The pulse generator should be explanted before the cremation of a deceased patient.
CAUTION
Device Incineration –
Never incinerate a pulse generator. Be sure
the pulse generator is explanted before a patient who has died
is cremated.
Explanted Devices – Return all explanted devices to BIOTRONIK.
12.1 Common Reasons to Explant a Pulse Generator
A pulse generator may be explanted emergently or at a physician’s discretion at any time subsequent
to an implant procedure. Reasons for explant include, but are not limited to: patient death; no output/
intermittent output; loss of capture/ sensing; inability to program/interrogate the pulse generator;
infection, EOS (normal or premature); system upgrade; physician preference for another pulse
generator model; and/or other reason(s) which may or may not be known to the pulse generator
manufacturer. Complications related to other portions of the pacing system (i.e., lead, patient) may also
result in pulse generator explant. Table 25 summarizes some of the more common reasons for pulse
generator explant.
Source Cause Possible Effect
Battery
Premature depletion due to high
programmed output or other
cause(s) resulting in excessive
battery current drain.
Output voltage decrease; rate decrease; loss of
capture; in creased pulse width; inability to program/
interrogate; sensing difficulty.
Circuitry
Electrical parameter changes
due to shorts, opens, or
component parametric drift
Electromagnetic Interference
(EMI) from large power
tools, industrial equipment,
electrocautery, defibrillation,
radiation therapy, RF ablation
therapy, etc.
No output; rate increase, rate decrease; reversion
to asyn chronous mode; loss of capture and/or
sensing
Permanent or temporary loss of output; output
inhibition; reversion to asynchronous mode with
rate change or instability; pacing synchronized to
interference; reversion to “Elective Replacement”
or electrical reset parameters; inability to program/
interrogate; other damage to circuit components
resulting in permanent or temporary parameter
changes.
Connector,
Setscrew,
etc.
Poor connection, intrusion of
body fluid.
Excessive current drain; early battery depletion;
intermittent or continuous loss of capture and/ or
sensing.
Leads
Displacement, fracture, loss of
insulation integrity.
Intermittent or continuous loss of capture and/
or sensing; excessive current drain; early battery
depletion.