Abbott Prodigy 3855 - Precautions

system, causing the cardiac system to respond inappropriately. To minimize or prevent the implanted cardiac
system from sensing the output of the neurosmulaon system, (1) maximize the distance between the
implanted systems; (2) verify that the neurosmulaon system is not interfering with the funcons of the
implanted cardiac system; and (3) avoid programming either device in a unipolar mode (using the device’s can
as an anode) or using neurosmulaon system sengs that interfere with the funcon of the implantable
cardiac system.
Explosive or ammable gases. Do not use the paent programmer in an environment where explosive or
ammable gas fumes or vapors are present, including hyperbaric chambers. The operaon of the paent
programmer could cause them to ignite, causing severe burns, injury, or death.
Operaon of machines, equipment, and vehicles. Paents using therapy that generates paresthesia should
turn o smulaon before operang motorized vehicles, such as automobiles, or potenally dangerous
machinery and equipment because sudden smulaon changes may distract them from properly operang it.
However, current data shows that most paents using
BurstDR™ smulaon therapy do not experience
paresthesia. For paents who do not feel paresthesia, sudden smulaon changes are less likely to occur and
distract them while operang motorized vehicles, machinery, or equipment.
Pediatric use. Safety and eecveness of neurosmulaon for pediatric use have not been established.
Pregnancy and nursing. Safety and eecveness of neurosmulaon for use during pregnancy and nursing
have not been established.
Use in paents with diabetes. Surgical complicaons and adverse eects may be more frequent and severe in
paents with diabetes. The following addional consideraons should be made for paents with diabetes:
▪
A pre-operave risk assessment should be performed for paents with diabetes who are at high risk for
▪
ischemic heart disease, those with autonomic neuropathy or renal failure, and paents with a
Hemoglobin A1C (HbA1c)
≥
8
%
(64 mmol/mol).
▪ Monitor the paent’s blood glucose levels in the perioperave period and instruct the paent to connue▪
to monitor glucose levels as they may uctuate as a response to surgery or to complicaons. Implanng
physicians or anesthesiologists should consult pracce guidelines for the intraoperave management of
paents with diabetes.
▪ Closely monitor paents for signs of infecon, delayed wound healing, or cerebrospinal uid (CSF)▪
leakage as the severity of these complicaons may be greater in paents with diabetes.
Smulaon modes. The BurstDR™ smulaon mode has not been evaluated for eecveness in the diabec
peripheral neuropathy (DPN) populaon.
Device components. The use of components not approved for use by Abbo Medical with this system may
result in damage to the system and increased risk to the paent.
Case damage. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from
exposure to baery chemicals.
Component disposal. Return all explanted IPGs to
Abbo Medical
for safe disposal. IPGs contain lithium ion
baeries as well as other potenally hazardous materials. Do not crush, puncture, or burn the IPG because
explosion or re may result.
Product materials. Neurosmulaon systems have materials that come in contact or may come in contact
with ssue. A physician should determine whether or not a paent may have an allergic reacon to these
materials before the system is implanted.
Precauons
The following precauons apply to this neurosmulaon system.
General Precauons
Physician training. Implanng physicians should be experienced in the diagnosis and treatment of chronic
pain syndromes and have undergone surgical and device implantaon training.
Paent selecon. It is extremely important to select paents appropriately for neurosmulaon. Thorough
psychiatric screening should be performed. Paents should not be dependent on drugs and should be able to
operate the neurosmulaon system.
Infecon. Follow proper infecon control procedures. Infecons related to system implantaon might require
that the device be explanted.
Implantaon of two systems. If two systems are implanted, ensure that at least 20 cm (8 in.) separates the
implanted IPGs to minimize the possibility of interference during programming.
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