CVRx BAROSTIMIPG1 Manual De Usuario
BAROSTIM NEO LEGACY REFERENCE GUIDE
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It is anticipated that subjects will be exposed to operative and post-operative risks similar to related surgical
procedures involving the neck and/or a pacemaker implant. These risks and potential risks of chronic device
based baroreflex activation may include, but are not limited to:
procedures involving the neck and/or a pacemaker implant. These risks and potential risks of chronic device
based baroreflex activation may include, but are not limited to:
Stroke – a neurological deficit lasting more than 24 hours or less than 24 hours with a brain imaging study
showing infarction
Transient ischemic attack (TIA) – a neurological deficit lasting less than 24 hours without evidence of
permanent cerebral infarction
Systemic embolization – downstream obstruction of a blood vessel by migration of loosened intravascular
plaque or clot
Surgical or anesthetic complications
Infection – the need for antibiotics or possible removal of the IPG
Wound Complication – including hematoma (i.e. bruising and/or swelling)
Arterial damage – including carotid artery rupture or hemorrhage (sudden and significant blood loss at a
Infection – the need for antibiotics or possible removal of the IPG
Wound Complication – including hematoma (i.e. bruising and/or swelling)
Arterial damage – including carotid artery rupture or hemorrhage (sudden and significant blood loss at a
site of blood vessel rupture that may require reoperation or transfusion)
Pain – an unpleasant sensory experience
Nerve Damage/Stimulation – including injury to or stimulation of Cranial, Marginal Mandibular,
Nerve Damage/Stimulation – including injury to or stimulation of Cranial, Marginal Mandibular,
Glossopharyngeal, Recurrent Laryngeal, Vagus and Hypoglossal Nerves (numbness in head and neck,
facial palsy/paralysis, altered speech, altered sense of taste, respiratory constriction, altered sensory and
motor function of tongue, altered sensory function of pharynx and oropharynx, altered sensation in
external auditory canal), stimulation of extravascular tissue (muscle twitching, pain, tingling, oral
sensations)
facial palsy/paralysis, altered speech, altered sense of taste, respiratory constriction, altered sensory and
motor function of tongue, altered sensory function of pharynx and oropharynx, altered sensation in
external auditory canal), stimulation of extravascular tissue (muscle twitching, pain, tingling, oral
sensations)
Hypotension – a decrease in systolic and diastolic blood pressure below normal levels that may result in
dizziness, fainting, and/or falls
Bradycardia – abnormally low heart rate
Atrial fibrillation – irregular rhythm in the upper heart chambers
Hypertensive crisis – uncontrolled rise in blood pressure
Exacerbation of heart failure
Respiratory – including low oxygen saturation, respiratory distress, shortness of breath
Tissue erosion/IPG migration – movement of device resulting in need for reoperation
Injury to baroreceptors – an injury that results in baroreflex failure
Fibrosis – replacement of normal tissue by the ingrowth of fibroblasts and the deposition of connective
Atrial fibrillation – irregular rhythm in the upper heart chambers
Hypertensive crisis – uncontrolled rise in blood pressure
Exacerbation of heart failure
Respiratory – including low oxygen saturation, respiratory distress, shortness of breath
Tissue erosion/IPG migration – movement of device resulting in need for reoperation
Injury to baroreceptors – an injury that results in baroreflex failure
Fibrosis – replacement of normal tissue by the ingrowth of fibroblasts and the deposition of connective
tissue
Allergic Reaction
General injury to user or patient – may be due to surgical procedure, device use, or interaction with other
General injury to user or patient – may be due to surgical procedure, device use, or interaction with other
devices
Need for reoperation – operation to explant/replace IPG or CSLs due to tissue damage, infection, and/or
device failure
Secondary operative procedure – An increase in the complexity and risk of secondary operative
procedures of the neck due to scar tissue and the presence of prosthetic material implanted for this device.
Death