Abbott Prodigy 3855 - Prescription and Safety Information; Intended Use; Indications for Use; Contraindications

Prescripon and Safety Informaon
Read this secon to gather important prescripon and safety informaon.
Intended Use
This rechargeable neurosmulaon system is designed to deliver low-intensity electrical impulses to nerve
structures. The system is intended to be used with leads and associated extensions that are compable with
the system.
Indicaons for Use
Abbo Medical spinal cord smulaon (SCS) systems are indicated as an aid in the management of chronic,
intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following:
failed back surgery syndrome, non‑surgical back pain (without prior surgery and not a candidate for back
surgery), and diabec peripheral neuropathy of the lower extremies.
Contraindicaons
This system is contraindicated for paents who are unable to operate the system or who have failed to receive
eecve pain relief during trial smulaon.
MRI Safety Informaon
Some models of this system are Magnec Resonance (MR) Condional, and paents with these devices may
be scanned safely with magnec resonance imaging (MRI) when the condions for safe scanning are met. For
more informaon about MR Condional neurosmulaon components and systems, including equipment
sengs, scanning procedures, and a complete lisng of condionally approved components, refer to the
MRI procedures clinician's manual for neurosmulaon systems (available online at
medical.abbo/manuals
).
For more informaon about MR Condional products, visit the
Abbo Medical
product informaon page at
neuromodulaon.abbo/MRI-ready
.
Warnings
The following warnings apply to this neurosmulaon system.
Poor surgical risks. Neurosmulaon should not be used on paents who are poor surgical risks or paents
with mulple illnesses or acve general infecons.
Magnec resonance imaging (MRI). Some paents may be implanted with the components that make up a
Magnec Resonance (MR) Condional system, which allows them to receive an MRI scan if all the
requirements for the implanted components and for scanning are met. A physician can help determine if a
paent is eligible to receive an MRI scan by following the requirements provided by
Abbo Medical
.
Physicians should also discuss any risks of MRI with paents.
Paents without an MR Condional neurosmulaon system should not be subjected to MRI because the
electromagnec eld generated by an MRI may forcefully dislodge implanted components, damage the device
electronics, and induce voltage through the lead that could jolt or shock the paent.
Diathermy therapy. Do not use short-wave diathermy, microwave diathermy, or therapeuc ultrasound
diathermy (all now referred to as diathermy) on paents implanted with a neurosmulaon system. Energy
from diathermy can be transferred through the implanted system and cause ssue damage at the locaon of
the implanted electrodes, resulng in severe injury or death.
Diathermy is further prohibited because it may also damage the neurosmulaon system components. This
damage could result in loss of therapy, requiring addional surgery for system implantaon and replacement.
Injury or damage can occur during diathermy treatment whether the neurosmulaon system is turned on
or o.
Electrosurgery devices. Electrosurgery devices should not be used in close proximity to an implanted
neurosmulaon system. Contact between an acve electrode and an implanted IPG, lead, or extension can
cause severe injury to the paent. If use of electrocautery is necessary, rst turn o the neurosmulaon
system.
Implanted cardiac systems. Physicians need to be aware of the risk and possible interacon between a
neurosmulaon system and an implanted cardiac system, such as a pacemaker or debrillator. Electrical
pulses from a neurosmulaon system may interact with the sensing operaon of an implanted cardiac
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