5
The OPTIMIZER Smart Mini
IPG uses its leads to detect the
electrical activity of your heart. Complications that can affect the
lead’s ability
to perform this fun
ction may occur. These include
:
•
A lead may become dislodged
from where it was placed
during implantation, necessitating re
-operation.
•
A lead may fracture or break producing a poor electrical
connection, necessitating re-operation.
The lead problems described above can occur at any time during
the implant life of a lead
.
Surgical correction is typically required.
3.2
Complications Associated with Device /
Charger Operation
Complications associated with device/charger operation include,
but are not limited to:
•
An OPTIMIZER Smart Mini
IPG may not properly sense
and deliver
CCM
signals due to a software or hardware
problem
, necessitating replacement.
•
An OPTIMIZER Smart Mini
IPG may detect environmental
interference and inappropriately deliver
CCM therapy.
See Sectio
n 6.4.
•
A Vesta Charger
may not function as designed due to a
software or hardware problem and not charge
your
OPTIMIZER Smart Mini IPG
as intended
. A replacement
c
harger will be required.
Summary of Contents for AIM HIGHer OPTIMIZER
Page 6: ...ii Implanted Medical Device Identification Card back ...
Page 62: ......
Page 65: ...NOTES ...
Page 66: ......
