Indications, Safety, and Warnings
Consult product labeling and MRI procedure guidelines prior to use for detailed disclosures.
Indications For Use:
The Algovita Spinal Cord Stimulation (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
Shortwave, microwave and/or therapeutic ultrasound diathermy must not be used on SCS patients. The energy generated by diathermy can be transferred through the SCS system, causing tissue damage at the lead site which may result in severe injury or death. Patients who have failed to receive effective pain relief during a stimulation trial should not receive the Algovita SCS System.
Strong electromagnetic interference (eg, electrocautery, RF, or microwave ablation) can result in serious patient injury or death, unexpected stimulation, or device malfunction or damage. Algovita SCS System interactions with other active implantable medical devices (such as pacemakers, defibrillators, or other) are not known; possible effects include sensing problems and inappropriate device responses. Burns may result if the IPG case is ruptured or pierced, exposing patient tissue to battery chemicals.
Under certain conditions, some fully implanted Algovita SCS Systems are magnetic resonance (MR) Conditional. Algovita Trial Stimulation Systems are not MR Conditional. Safety and effectiveness of SCS have not been established for pediatric patients, for use during pregnancy, or for use with nursing patients. Certain therapies or procedures (eg, radiotherapy, lithotripsy, TENS units, external defibrillation, or ultrasound) may turn stimulation off or may cause permanent damage to the neurostimulator, resulting in loss of therapy or additional surgery. Patients should avoid extreme environmental temperatures or large atmospheric pressure variations (eg, scuba diving below 5 meters or hyperbaric chamber pressures exceeding 1.5 atmospheres absolute pressure) to avoid adverse effects to the patient or damage to the neurostimulator. Changes in posture or abrupt movements may cause decreases, or uncomfortable or painful increases in the perceived stimulation level. Patients should turn stimulation off before operating a motorized vehicle or potentially dangerous machinery or equipment, as sudden stimulation changes may distract patients from attentive operation.
Adverse Events May Include:
Lead migration, allergic response or tissue reaction to materials, hematoma or seroma at neurostimulator site, skin erosion or pain at implant sites, reticular chest wall stimulation, skin irritation at the recharge site, loss of pain relief, uncomfortable stimulation or ineffective pain relief due to system issues, epidural mass formation at the lead, and surgical risks (infection, cerebrospinal fluid leakage, epidural hemorrhage, hematoma, seroma, and paralysis).