Percutaneous Lead Placement In The Epidural Space - Boston Scientific SC-2408 Serie Gebrauchsanweisung

Avista™ MRI xxcm Contact Lead Kit
Lead Handling
Physician training is required. Boston Scientific also recommends that implanting physicians read all
product labeling prior to using our devices.
• Avoid damaging the lead with sharp instruments or excessive force during surgery.
• Do not sharply bend or kink the lead.
WARNING: If the patient receives an MRI scan, broken conductor wires and damage to the lead body could
increase the risk of tissue heating, which could cause tissue damage or serious patient injury.
• Do not tie suture(s) directly to the lead; 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.

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 (Figure 4).
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 (Figure 4). 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.
WARNING: Do not abandon leads or any portion of leads or extensions in the patient when changing components
or permanently explanting the IPG. Abandoned components may prevent the patient from being allowed MRI
scans in the future due to concerns of lead electrode heating that can result in tissue damage.
Avista™ MRI xxcm Contact Lead Kit
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Figure 4: Angle of Incision Needle