Abbott Prodigy 3855 - Adverse Effects; Patient Selection

Hospital and Medical Environments
High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic
lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. If lithotripsy must be used, do
not focus the energy near the IPG.
Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause mechanical damage to
an implanted neurosmulaon system if used directly over the implanted system.
External debrillators. The safety of discharge of an external debrillator on paents with implanted
neurosmulaon systems has not been established.
Therapeuc radiaon. Therapeuc radiaon may damage the electronic circuitry of an implanted
neurosmulaon system, although no tesng has been done and no denite informaon on radiaon eects
is available. Sources of therapeuc radiaon include therapeuc X‑rays, cobalt machines, and linear
accelerators. If radiaon therapy is required, the area over the implanted IPG should be shielded with lead.
Home and Occupaonal Environments
Electromagnec interference (EMI). Certain commercial electrical equipment (for example, arc welders,
inducon furnaces, and resistance welders), communicaon equipment (for example, microwave
transmiers, linear power ampliers, and high power amateur transmiers), and high voltage power lines
may generate sucient EMI to interfere with the operaon of the neurosmulaon system if approached too
closely.
Adverse Eects
In addion to those risks commonly associated with surgery, the following risks are associated with implanng
or 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 IPG 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 IPG site▪
▪ Seroma (mass or swelling) at the IPG site▪
▪ Allergic or rejecon response to implant materials▪
▪
Implant migraon or skin erosion around the implant
▪
▪ Baery failure▪
▪ Changes in blood glucose levels in response to any adverse eect.▪
NOTE: Paents with diabetes may have increased risks of infecon, problems healing around the
surgical site, and complicaons common to any surgical procedure. The severity of any surgical
complicaon may be greater in paents with diabetes, parcularly those with inadequate pre-
operave glycemic control. For adverse eects observed in SCS clinical studies, refer to the clinical
summaries manual for SCS systems.
Paent Selecon
Before a system is implanted, paents should have undergone a successful trial screening period and should
have demonstrated a willingness to parcipate in the treatment protocol. For best results, paents should be
fully informed about the therapy risks and benets, implantaon procedure, follow-up requirements, and self-
care responsibilies.
Neurosmulaon with this device is appropriate for paents who
▪
Meet the indicaons for use
▪
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