Adverse Effects; Patient Selection - Abbott Prodigy 3855 System Manual

Hospital and Medical Environments
High-output ultrasonics and lithotripsy.
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.
an implanted neurostimulation system if used directly over the implanted system.
External defibrillators.
neurostimulation systems has not been established.
Therapeutic radiation.
neurostimulation system, although no testing has been done and no definite information on radiation effects
is available. Sources of therapeutic radiation include therapeutic X‑rays, cobalt machines, and linear
accelerators. If radiation therapy is required, the area over the implanted IPG should be shielded with lead.
Home and Occupational Environments
Electromagnetic interference (EMI).
induction furnaces, and resistance welders), communication equipment (for example, microwave
transmitters, linear power amplifiers, and high power amateur transmitters), and high voltage power lines
may generate sufficient EMI to interfere with the operation of the neurostimulation system if approached too
closely.

Adverse Effects

In addition to those risks commonly associated with surgery, the following risks are associated with implanting
or using this neurostimulation system:
▪ ▪ Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at
high outputs (If either occurs, turn off your IPG 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 IPG site
▪ ▪
Seroma (mass or swelling) at the IPG site
▪ ▪
Allergic or rejection response to implant materials
▪ ▪ Implant migration or skin erosion around the implant
▪ ▪
Battery failure
▪ ▪
Changes in blood glucose levels in response to any adverse effect.
NOTE: Patients with diabetes may have increased risks of infection, problems healing around the
surgical site, and complications common to any surgical procedure. The severity of any surgical
complication may be greater in patients with diabetes, particularly those with inadequate pre-
operative glycemic control. For adverse effects observed in SCS clinical studies, refer to the clinical
summaries manual for SCS systems.

Patient Selection

Before a system is implanted, patients should have undergone a successful trial screening period and should
have demonstrated a willingness to participate in the treatment protocol. For best results, patients should be
fully informed about the therapy risks and benefits, implantation procedure, follow-up requirements, and self-
care responsibilities.
Neurostimulation with this device is appropriate for patients who
▪ ▪
Meet the indications for use
The use of high-output devices, such as an electrohydraulic
The use of ultrasonic scanning equipment may cause mechanical damage to
The safety of discharge of an external defibrillator on patients with implanted
Therapeutic radiation may damage the electronic circuitry of an implanted
Certain commercial electrical equipment (for example, arc welders,
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