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Instructions for Use
Physician training is required. Boston Scientific also recommends that implanting physicians read all
product labeling prior to using our devices.
Lead, Lead Extension, and Splitter Handling and Storage
• Avoid damaging the lead with sharp instruments or excessive force during surgery.
• Do not sharply bend or kink the lead, extension, or splitter.
• Do not tie suture(s) directly to the lead, extension, or splitter body; use the provided suture
sleeves.
• For the Percutaneous Leads avoid forcing the lead into the epidural space by carefully
clearing a path using the lead blank.
• Avoid pulling an implanted lead taut; provide a stress relief loop at the insertion site to
minimize tension on the lead.
• Avoid handling the lead with sharp instruments; use only rubber-tipped forceps.
• Take care when using sharp instruments such as hemostats or scalpels to prevent damaging
the lead.
• Wipe off any body fluids from the lead connector end before connecting it to any other
component. Fluid contamination of these connections could compromise the integrity of the
stimulation circuit.
• Wipe off any body fluids from the lead stylet before inserting or reinserting it into the lead.
Store components between 0 °C and 45 °C (32 °F and 113 °F) in an area where they are not exposed to
liquids or excessive moisture. Temperatures outside of the stated range can cause damage.
Percutaneous Lead Placement in the Epidural Space
1. Position, prep and drape the patient in the usual accepted manner. Inject a local anesthetic at the
needle insertion site.
2. Under fluoroscopic guidance, place the insertion needle into the epidural space with the bevel facing
up using an angle of 45° or less.
CAUTION: Use only an insertion needle provided by Boston Scientific. Other needles may damage
the lead. The stamped number "14" on the needle hub (or the triangle on the hub of the curved Epimed
needle, sold separately) corresponds to the orientation of the bevel, which must face up. Turning the
bevel ventral (down) may result in lead damage. An angle of more than 45° increases the risk of lead
damage.
WARNING: The angle of the insertion needle should be 45° or less. Steep angles increase the
insertion force of the stylet and also present more of an opportunity for the stylet to pierce the lead and
cause tissue damage.
Instructions for Use
Percutaneous Leads Directions for Use
90970887-03 Rev A
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