Abbott 3599 - Device and Patient Response Effects

▪ 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 rejecon response to device or 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.
Safety and Eecveness Studies
For informaon that supports the clinical use of this neurosmulaon system, refer to the clinical
summaries manual for spinal cord smulaon (SCS) systems (available online at
medical.abbo/manuals
).
This neurosmulaon 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
eecveness of this neurosmulaon system.
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