• Exposure to magnetic resonance imaging (MRI) can result in heating of tissue,
image artifacts, induced voltages in the IPG and/or leads, and lead
dislodgement
• Epidural Mass Formation at Lead: Though incidence is rare (14 cases over 30
years; see reference below), over the course of months or years, permanent
implantation of an SCS paddle lead or percutaneous lead can result in epidural
mass formation around the lead, which could compress the spinal cord. The
effect of spinal cord compression can range from muscle weakness to
progressive quadriparesis. If a patient with a SCS lead presents with a new
neurological deficit, spinal cord compression due to reactive tissue mass
formation should be considered as a potential cause. If an epidural mass is
identified in a patient who is asymptomatic, periodic monitoring should be
considered. For more information please visit:
http://professional.medtronic.com/wcm/groups/mdtcom_sg/@mdt/@neuro/
documents/documents/scs-compression-ltr-feb2014.pdf
Adverse Events Associated with the External Device Components
• Tissue reaction or allergy to external materials
• Uncomfortable heating effects, discomfort, or burn
If you have questions or are experiencing adverse events, contact your doctor.
Please consult the Clinical Summary (P/N 12057) for additional information regarding
clinical studies of the Senza System and safety and effectiveness data.
IMPLANTATION SURGERY
If you and your doctor decide to proceed with SCS therapy, the first step is a trial
phase. Typically, your doctor will first place a lead in your body. This procedure may
be done under local anesthetic, so you are awake and aware of what is going on. You
may be given medication to help you relax and some numbing medicine for the
insertion site. The lead is placed in your body during a minor procedure usually
without an incision. Most patients are able to leave the hospital the same day,
depending on physical condition, the procedure, and doctor’s preferences. Once the
lead is in the body, you will typically use the device over a period of days as decided by
your doctor. This provides an opportunity for you and your doctor to experience the
system on a temporary basis and evaluate the how well the device might work for
you.
Patient Manual 11052 Rev A (2015-01-16) 19
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