Adverse Effects; System Overview - Abbott Eterna 32400 Clinician Manual

Home and Occupational Environments
Security, antitheft, and radiofrequency identification (RFID) devices.
used at entrances or exits of department stores, libraries, and other public places, and airport security
screening devices may affect stimulation. Additionally, RFID devices, which are often used to read
identification badges, as well as some tag deactivation devices, such as those used at payment counters at
stores and loan desks at libraries, may also affect stimulation. Patients who are implanted with nonadjacent
multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary
increase in their perceived stimulation, which some patients have described as uncomfortable or jolting.
Patients should cautiously approach such devices and should request help to bypass them. If they must go
through a gate or doorway containing this type of device, patients should turn off their generator and
proceed with caution, being sure to move through the device quickly.
Scuba diving or hyperbaric chambers.
their physician to discuss the effects of high pressure on their implanted system. Implanted systems with
non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. Patients
with implanted Abbott leads should avoid scuba diving in more than 30 m (100 ft) of water or entering
hyperbaric chambers above 4.0 atmospheres absolute (ATA) for any length of time, as this may damage the
neurostimulation system. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less
than 60 minutes are recommended.
Wireless use restrictions.
wireless technology) may be restricted. Such restrictions may apply aboard airplanes, near explosives, or in
hazardous locations. If you are unsure of the policy that applies to the use of this device, please ask for
authorization to use it before turning it on.

Adverse Effects

In addition to those risks commonly associated with surgery, the following risks are associated with using
this neurostimulation system:
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Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation
at high outputs (If either occurs, turn off your generator immediately.)
▪ ▪
Undesirable changes in stimulation, which may be related to cellular changes in tissue around the
electrodes, changes in electrode position, loose electrical connections, or lead failure
▪ ▪
Stimulation in unwanted places (such as radicular stimulation of the chest wall)
▪ ▪
Lead migration, causing changes in stimulation or reduced pain relief
▪ ▪
Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a
lead in the epidural space
▪ ▪
Cerebrospinal fluid (CSF) leakage
▪ ▪
Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant
▪ ▪
Persistent pain at the electrode or generator site
▪ ▪
Seroma (mass or swelling) at the generator site
▪ ▪
Allergic or rejection response to implant materials
▪ ▪
Implant migration or skin erosion around the implant
▪ ▪
Battery failure

System Overview

This neurostimulation system is designed to deliver electrical stimulation to nerve structures. The
neurostimulation system includes the following main components:
▪ ▪
Generator and accessories
▪ ▪
Charger and accessories
▪ ▪
Leads
▪ ▪
Clinician programmer application on clinician programmer device
▪ ▪
Patient controller application on patient controller device
▪ ▪
Patient magnet
Before diving or using a hyperbaric chamber, patients should contact
In some environments, the use of wireless functions (for example, Bluetooth®
Some antitheft devices, such as those
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