Safety And Effectiveness Studies - Abbott 3599 Clinician Manual

▪ ▪ 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 implant site
▪ ▪
Allergic or rejection response to device or 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.

Safety and Effectiveness Studies

For information that supports the clinical use of this neurostimulation system, refer to the clinical
summaries manual for spinal cord stimulation (SCS) systems (available online at medical.abbott/manuals).
This neurostimulation system is similar in technology and intended use to the systems reported in the
literature and clinical studies. Therefore, the literature and clinical studies represent the safety and
effectiveness of this neurostimulation system.
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