Abbott Eterna 32400 - Lead Movement and Patient Training; Sterilization, Storage, and Handling; Sterilization, Storage, and Handling Guidelines; Hospital and Medical Environments

Home and Occupaonal Environments
Security, anthe, and radiofrequency idencaon (RFID) devices. Some anthe devices, such as those
used at entrances or exits of department stores, libraries, and other public places, and airport security
screening devices may aect smulaon. Addionally, RFID devices, which are oen used to read
idencaon badges, as well as some tag deacvaon devices, such as those used at payment counters at
stores and loan desks at libraries, may also aect smulaon. Paents who are implanted with nonadjacent
mulple leads and paents who are sensive to low smulaon thresholds may experience a momentary
increase in their perceived smulaon, which some paents have described as uncomfortable or jolng.
Paents should cauously approach such devices and should request help to bypass them. If they must go
through a gate or doorway containing this type of device, paents should turn o their generator and
proceed with cauon, being sure to move through the device quickly.
Scuba diving or hyperbaric chambers. Before diving or using a hyperbaric chamber, paents should contact
their physician to discuss the eects of high pressure on their implanted system. Implanted systems with
non-Abbo leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. Paents
with implanted Abbo leads should avoid scuba diving in more than 30 m (100 ) of water or entering
hyperbaric chambers above 4.0 atmospheres absolute (ATA) for any length of me, as this may damage the
neurosmulaon system. For less than 30 m (100 ) of water or pressures below 4.0 ATA, duraons of less
than 60 minutes are recommended.
Wireless use restricons. In some environments, the use of wireless funcons (for example, Bluetooth®
wireless technology) may be restricted. Such restricons may apply aboard airplanes, near explosives, or in
hazardous locaons. If you are unsure of the policy that applies to the use of this device, please ask for
authorizaon to use it before turning it on.
Adverse Eects
In addion to those risks commonly associated with surgery, the following risks are associated with using
this neurosmulaon system:
▪ Unpleasant sensaons or motor disturbances, including involuntary movement, caused by smulaon▪
at high outputs (If either occurs, turn o your generator immediately.)
▪ Undesirable changes in smulaon, which may be related to cellular changes in ssue around the▪
electrodes, changes in electrode posion, loose electrical connecons, or lead failure
▪
Smulaon in unwanted places (such as radicular smulaon of the chest wall)
▪
▪ Lead migraon, causing changes in smulaon or reduced pain relief▪
▪ Epidural hemorrhage, hematoma, infecon, spinal cord compression, or paralysis from placement of a▪
lead in the epidural space
▪ Cerebrospinal uid (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 rejecon response to implant materials▪
▪
Implant migraon or skin erosion around the implant
▪
▪ Baery failure▪
System Overview
This neurosmulaon system is designed to deliver electrical smulaon to nerve structures. The
neurosmulaon system includes the following main components:
▪ Generator and accessories▪
▪ Charger and accessories▪
▪ Leads▪
▪
Clinician programmer applicaon on clinician programmer device
▪
▪
Paent controller applicaon on paent controller device
▪
▪
Paent magnet
▪
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