Tabla de contenido
Idiomas disponibles
Idiomas disponibles
Prescription Information
Indication
CervicalStim is a noninvasive, pulsed electromagnetic bone growth stimulator
indicated as an adjunct to cervical fusion surgery in patients at high-risk for
non-fusion.
Contraindication
There are no known contraindications for CervicalStim as an adjunct to
cervical spine fusion surgery.
Warnings
• Do not use CervicalStim if you have a cardiac pacemaker or defibrillator
because it may interfere with the operation of your pacemaker or
defibrillator. If you use CervicalStim and it affects your pacemaker or
defibrillator, it may injure your heart. Consult your cardiologist before
using CervicalStim.
• Remove CervicalStim prior to any imaging procedures (e.g., CT scan,
MRI, etc.). If you wear CervicalStim during these procedures, you could
be injured, the imaging being produced may be ruined, and/or the
CervicalStim could be damaged.
Precautions
• Avoid using CervicalStim if you do not understand the instructions your
doctor has given you. If you use CervicalStim incorrectly, it may harm you
or may not help your healing process.
• CervicalStim has not been evaluated in treating patients with the
following conditions: osseous or ligamentous spinal trauma, spondylitis,
Paget's disease, moderate to severe osteoporosis, metastatic cancer,
renal disease, rheumatoid arthritis, uncontrolled diabetes mellitus,
patients prone to vascular migraine headache, seizure, epilepsy, thyroid
conditions, or neurological diseases.
• Animal reproductive studies performed with this device did not show any
harmful effects in animals. However, the safety of this device for use on
patients who are pregnant or nursing has not been established.
Adverse Effects Summary
Adverse effects may be experienced when using CervicalStim. These adverse
effects may include increased pain, numbness and tingling, headache,
migraines, and nausea. These effects may or may not be directly related to
use of CervicalStim. Any adverse effects that are related to CervicalStim should
stop when you discontinue use.
See the Adverse Events Table for a list of all adverse events reported during
the clinical study.
1
Capítulos
Tabla de contenido
