Vectris™ SureScan® MRI 1x8
Subcompact
®
Vectris™ SureScan
MRI 1x8
Compact
Lead kit
Implant manual
Rx only
977A160
977A175
977A190
977A260
977A275
977A290
Medtronic, Medtronic logo, and Further, Together are trademarks of Medtronic. InjexTM,
SureScan
TM
, TitanTM, and VectrisTM are trademarks of a Medtronic company.
977A1, 977A2 series 2019-10-01 English 3
4 English 977A1, 977A2 series 2019-10-01
Table of contents
Description 7
Neurostimulation systems with SureScan MRI Technology 7
Package contents 7
Device specifications 8
Implanted components and MRI scans 10
Information available for the system:
The information for prescribers manual provides information about
contraindications, warnings, precautions, adverse events, sterilization, patient
selection, individualization of treatment, and component disposal.
For customers in Japan, the appropriate package insert provides information
about indications, safety, contraindications, warnings, precautions, and adverse
events.
The indications sheet provides information about indications and related
information.
The system eligibility, battery longevity, specifications manual provides
information about neurostimulator selection, battery longevity calculations, and
battery characteristics.
MRI guidelines provide information about any MRI conditions and MRI-specific
contraindications, warnings, and precautions for MRI scans with the
neurostimulation system.
Product manuals, such as programming guides, recharging guides, and implant
manuals provide device descriptions, package contents, device specifications,
product-specific warnings and precautions, and instructions for use.
! USA
The clinical summary provides information about the clinical study results
for the neurostimulation system.
977A1, 977A2 series 2019-10-01 English 5
Implant criteria for full-body MRI scan eligibility 10
When changing components 11
Identifying implanted Vectris SureScan MRI leads 11
Instructions for use 13
Preparing for surgery 13
Placing a percutaneous lead 13
Testing stimulation intraoperatively 15
Anchoring the lead and creating strain-relief loops 16
Removing an anchor from the lead 21
Creating a subcutaneous pocket for the neurostimulator 23
Tunneling the lead for direct connection to a neurostimulator 24
Appendix: Trial procedures 26
Tunneling the percutaneous extension for the trial 26
Connecting the percutaneous extension to the lead and closing the incision for the
trial 27
Preparing components for the trial 28
Removing the percutaneous extension after the trial 29
6 English 977A1, 977A2 series 2019-10-01
Description
The Medtronic Vectris SureScan MRI 1x8 Subcompact Models 977A160, 977A175, and
977A190 Leads and the Vectris SureScan MRI 1x8 Compact Models 977A260, 977A275,
and 977A290 Leads are part of a neurostimulation system for pain therapy.
Neurostimulation systems with SureScan MRI Technology
When a Medtronic neurostimulation system with SureScan MRI Technology is implanted as
directed (see "Implant criteria for full-body MRI scan eligibility" on page 10), a patient's full
body may be eligible for MRI scans under specific conditions, ie, any part of the patient's
anatomy can be scanned when specific conditions are met.
For the MRI conditions and MRI-specific warnings and precautions for conducting an MRI
scan, refer to the MRI guidelines for Medtronic neurostimulation systems for chronic pain
instructions for use manual.
Package contents
Lead
▪
Injex anchor with anchor dispenser tool
▪
Guide wire
▪
Needles (epidural, modified Tuohy):
▪
curved tip, 14 gauge, 8.9 cm
–
straight tip, 14 gauge, 8.9 cm
–
Stylets:
▪
bent, 0.30 mm diameter (green stylet handle and blue cap; inserted in the lead)
–
straight, 0.30 mm diameter (green stylet handle and green cap)
–
Tunneling tools: tunneling rod, tunneling tip (narrow), tube (passing straw)
▪
Product literature
▪
Warranty card
▪
Registration form
▪
977A1, 977A2 series 2019-10-01 English 7
Device specifications
The lead has electrodes on the distal end; the proximal (connector) end fits into an 8conductor connector. A stylet has been inserted into the proximal end of the lead to aid in
positioning the lead.
Lead contact distance
Electrode
length
Electrode numbers
Electrode distance
Electrode
spacing
Lead contact
spacing
0
contact
length
contact
length
ProximalDistal
Lead
Stylet handle
length
Figure 1. Electrode, lead contact, and stylet (shown with bent stylet).
8 English 977A1, 977A2 series 2019-10-01
Table 1. Device specifications for leads: Models 977A1 and 977A2 series
Description Models 977A160,
Connector Octapolar,
Conductor resistance
c,d
977A175, 977A190
in-line
Models 977A260,
977A275, 977A290
Octapolar,
in-line
1.6 Ω per cm 1.6 Ω per cm
Length 60, 75, 90 cm 60, 75, 90 cm
Diameter (lead body) 1.3 mm 1.3 mm
Distal (electrode) end
Number of electrodes 8 8
Electrode shape Cylindrical Cylindrical
Electrode length 3.0 mm 3.0 mm
Electrode spacing 1.5 mm 4.0 mm
Electrode distance 34.5 mm 52.0 mm
Distal tip distance Not applicable Not applicable
Radiopaque tip marker No No
Proximal (connector) end
Lead contact length 1.5 mm 1.5 mm
'0' contact length 3.0 mm 3.0 mm
Lead contact spacing 2.8 mm 2.8 mm
Lead contact distance 22.5 mm 22.5 mm
Stylet handle length 29.0 mm 29.0 mm
Stylet wire diameter 0.30 mm 0.30 mm
a
All measurements are approximate.
b
The numbers that follow the base model number in a series denote the lead length in centimeters.
c
Electrical resistance of this device only.
d
Resistance is proportional to length: long lengths have higher resistance that may limit the amplitude.
a,b
977A1, 977A2 series 2019-10-01 English 9
Table 2. Material of components in the Models 977A1 and 977A2 series lead package
Component Materials
Lead Epoxy, fluoropolymer,
Anchor Silicone rubber
Materials and
substances to
which the patient
can be exposed
Anchor dispenser tool Polycarbonate,
Guide wire Stainless steel
Needles (curved, straight) Stainless steel
Stylets (bent, straight) Polypropylene, stainless
Tunneling rod Stainless steel
Tunneling tip Stainless steel
Tube (passing straw) Fluoropolymer
MP35N, platinum-iridium,
polyurethane, tantalum
polytetrafluoroethylene,
stainless steel
steel
Implanted components and MRI scans
Implant criteria for full-body MRI scan eligibility
Caution: To allow a patient full-body MRI scan eligibility under specific conditions,
implant a Medtronic neurostimulation system with SureScan MRI Technology as
follows:
Use only SureScan MRI neurostimulation system components (eg, leads and
▪
neurostimulators).
Note: Extension model numbers in the 3708 series (eg, 37081, 37082, 37083) are
not full-body MRI scan eligible.
Implant the neurostimulator in the buttocks, abdomen, or flank (ie, the lateral and
▪
posterior region between the ribs and pelvis).
Place the lead tip(s) in the spinal epidural space.
▪
Explant any previously abandoned pain leads or extensions that may be in the
▪
patient (ie, leads or extensions, or portions of, that are not connected to a
neurostimulator).
Note: Confirm MRI compatibility of any other implanted medical devices. Other
implanted medical devices may limit or restrict MRI scans.
Enter all component model number and implant location information using the
▪
clinician programmer.
10 English 977A1, 977A2 series 2019-10-01
If the above implant criteria are not met, the patient will not have a neurostimulation
system with full-body MRI scan eligibility. MRI scan eligibility will be restricted.
For the MRI conditions and MRI-specific warnings and precautions for conducting an
MRI scan, refer to the MRI guidelines for Medtronic neurostimulation systems for
chronic pain instructions for use manual. MR scans performed under different
conditions can result in patient injury or damage to the implantable device.
When changing components
Warning: Before explanting and replacing an existing neurostimulator, print a report
from the existing neurostimulator that shows implanted and any abandoned
component information. When adding, changing, or removing neurostimulators, leads,
extensions, and accessories, always program up-to-date component model numbers,
implant locations, and any abandoned component information to re-establish MRIscan eligibility.
If this information is not updated or is entered incorrectly, MRI scan-type eligibility
data will be inaccurate, and the patient is at risk for one of the following:
The patient is allowed to have an MRI scan inappropriate for the implanted
▪
components, which could cause tissue heating, resulting in tissue damage or
serious patient injury.
The patient is unnecessarily restricted from having an MRI scan.
▪
Identifying implanted Vectris SureScan MRI leads
To identify an implanted Vectris SureScan MRI lead, use x-ray imaging and look for a
transition of the lead body diameter size near the lead electrodes. The portion of the lead
body with the braiding has a wider radiographic diameter than the lead body at the leadelectrode (distal) end (Figure 2).
Note: X-ray identification of the lead should only be used to confirm the accuracy of the
component and implant location information entered into the neurostimulator. Do not use
977A1, 977A2 series 2019-10-01 English 11
x-ray identification to conclude that the entire neurostimulation system is full-body MRI scan
eligible.
Vectris SureScan MRI lead (top)
Lead body radiographic diameter transition near distal end
Braiding
Lead electrode
Lead body without braiding
Lead body without SureScan MRI Technology (bottom)
Figure 2. A Vectris SureScan MRI lead (with braiding) compared with a lead without the
braiding.
12 English 977A1, 977A2 series 2019-10-01
Instructions for use
Implanting physicians should be experienced in epidural-access procedures and should be
thoroughly familiar with all product labeling.
Cautions:
Do not bend, kink, or stretch the lead or extension, which may damage the
▪
component.
Do not use any instrument to handle the lead. The force may compress the lead,
▪
resulting in the inability to insert or withdraw the stylet.
Do not use saline or other ionic fluids at connections, which could result in a short
▪
circuit.
Cautions:
Do not bend or kink the stylet, which may damage the component.
▪
When reinserting a stylet, use care because too much pressure on the stylet
▪
could damage the lead, resulting in intermittent or loss of stimulation.
Caution: Do not abandon pain leads or any portions of leads or extensions in the
patient when changing components or permanently explanting the neurostimulator.
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.
Preparing for surgery
Before opening the lead package, verify the model number, use-by date, lead length, and
connector type.
Note: Select a lead length that is long enough for strain-relief loops and direct connection to
a SureScan MRI neurostimulator.
Placing a percutaneous lead
Warning: As with any spinal procedure, the risk of serious injury to the patient (eg,
hemorrhage, hematoma, or paralysis) increases as location of the selected needle
insertion site progresses up the vertebral column—from a lower risk at a lumbar
location to a higher risk at a cervical location. Select a vertebral location that provides
the widest and easiest access to the epidural space during needle insertion to reduce
the risk of serious patient injury resulting from direct trauma to the spinal cord.
Warning: Do not make custom bends to the distal (electrode) end of the lead with or
without the stylet in the lead. Bending the lead at the distal end can break the
conductor wires and render the respective electrode inoperable, which may require
additional surgery to restore therapy. If the patient receives an MRI scan, broken
conductor wires increase the risk of tissue heating, which could cause tissue damage
or serious patient injury.
977A1, 977A2 series 2019-10-01 English 13
Caution: Do not place the lead electrodes in locations outside of the epidural spine. If
other lead electrode locations are used (eg, neck or head), MRI scan eligibility will be
restricted. The patient will not be full-body eligible for MRI scans.
Caution: To reduce the risk of lead damage that may result in intermittent stimulation
or loss of stimulation, requiring additional surgery to replace the lead:
use only the modified Tuohy needle supplied in the kit.
▪
use a shallow needle-insertion angle (45° or less) when inserting or withdrawing
▪
the needle into or out of the epidural space.
1. Make an incision at the needle-entry site to the depth of the subcutaneous fascia.
2. Using a paramedial approach and under fluoroscopy, insert the needle (included in the
kit) into the epidural space at the appropriate angle until you encounter resistance
from the ligamentum flavum.
Caution: Use a paramedial approach for needle placement so that lead
placement is not on the midline. Over time, ligament or spinous process
movement may cause damage to a lead implanted on the midline, resulting in
loss of stimulation and requiring additional surgery to restore therapy.
3. Confirm needle location under fluoroscopy.
4. After rotating the needle so that the beveled edge faces cephalad, remove the needle
stylet.
5. Advance the needle and confirm entry into the epidural space (eg, using the loss-ofresistance technique with air or sterile [United States Pharmacopeia—USP] water).
Caution: Do not use contrast media or a saline flush. Contrast media may
obscure the field of view and a saline flush may increase the difficulty of lead
placement.
6. For a second lead, repeat steps 1 to 5 noting these recommendations:
Implant the second lead parallel to the first lead and approximately 1 to 3 mm
▪
lateral of the physiological midline.
Introduce the second lead one vertebral space below the first lead to help prevent
▪
nicking or cutting the first lead and to allow sufficient space for suturing both lead
anchors.
Stagger the lead tips or place them several vertebral spaces apart, depending on
▪
the position that produces the most effective paresthesia.
7. After inserting the guide wire through the needle, advance the guide wire no farther
than 1 to 3 cm past the needle tip. Next, remove the guide wire from the needle.
Note: If the guide wire track deviates from the intended pathway, steering and
manipulating the lead will be more difficult.
14 English 977A1, 977A2 series 2019-10-01
8. Using fluoroscopy, slowly insert the lead through the needle and advance the lead to
the initial target placement site. A stylet may need to be reinserted.
Notes:
The bent stylet is keyed so that the flat notch of the stylet handle faces the same
▪
direction as the distal bent tip.
Ensure the lead electrodes are completely out of the distal end of the needle
▪
when changing a stylet. If the lead electrodes still partially remain in the needle,
the force needed to insert the stylet may increase.
The force to insert and withdraw the stylet increases as the needle angle
▪
increases.
Before advancing the lead, ensure the stylet is fully inserted.
▪
If resistance is felt while steering (with the stylet inserted), rotate the lead and
▪
stylet or pull back slightly to ensure the lead is not stuck. Use short, firm
movements to advance the lead.
9. After verifying the lead electrode position under fluoroscopy (anterior-posterior and
lateral views), compare that location with the location that is expected to have the
highest probability of paresthesia coverage.
Notes:
To increase lead stability, insert enough lead length to extend at least three
▪
vertebral bodies into the epidural space.
Position the lead so that the center bipole electrodes (eg, electrodes 3 and 4 on
▪
an octapolar lead) will be active. If lead migration occurs, effective stimulation
may be regained through programming adjustments instead of surgical
repositioning.
Testing stimulation intraoperatively
1. Refer to the instructions associated with the external devices (for example, external
neurostimulator or trialing cable) used in intraoperative test stimulation.
2. Identify optimal stimulation parameters, beginning at a pulse width of 210 to 240 μs
and a rate of 30 Hz.
Note: Ensure that the patient can provide immediate feedback.
3. Increase the amplitude (V) or intensity (mA) beginning from the lowest setting while
asking the patient closed-ended questions to identify the perception threshold (the
setting at which the patient first perceives paresthesia), the discomfort threshold (the
setting at which paresthesia is beyond the patient’s tolerance), and the paresthesia
coverage.
Note: If good paresthesia coverage is not attained, change electrode settings before
repositioning the lead to confirm the direction of lead movement.
4. If two leads were placed, repeat steps 2 – 3 for the second lead; optimize paresthesia
coverage using both leads.
977A1, 977A2 series 2019-10-01 English 15
5. In the patient’s chart, document the lead position that provided appropriate stimulation
coverage (ie, record the settings and patient responses and include a fluoroscopic
image of the final lead position).
Anchoring the lead and creating strain-relief loops
Note: The Injex anchor in this lead kit has been specifically designed for securing these
leads.
Caution: Use only Injex anchors to secure the SureScan MRI lead in this kit. Other
anchors are not recommended as they may damage the lead (eg, Titan or Twist-Lock
anchors) or may not provide sufficient anchoring strength (eg, EZ, two-wing, threewing anchors), resulting in lead migration. Lead damage or lead migration may require
additional surgery to restore therapy.
1. Prepare the anchor site by making a 5 to 7 cm (2.0 to 2.8 in) longitudinal incision
around the needle shaft, dissecting down to the supraspinous ligament, and
establishing hemostasis.
2. Disconnect the stylet from the lead. Partially expose but do not completely withdraw
the stylet.
3. While maintaining lead position, use minimal force to remove the needle and stylet.
Caution: Use minimal traction to remove the needle because quick or sudden
removal may dislodge the lead.
4. Thread 2-0 nonabsorbable suture material (such as silk or some types of braided
polyester mesh) through the ligament or fascia in preparation for tying the anchor to
secure the lead to the anchor site tissue in step 11.
Cautions:
Do not use polypropylene suture material on silicone components.
▪
Polypropylene may damage the component, resulting in component failure.
Do not overtighten ligatures on the anchor or connector boot. Ligatures that
▪
are too tight may damage the component.
5. Locate the anchor dispenser tool with a preloaded anchor (Figure 3).
16 English 977A1, 977A2 series 2019-10-01
Slot
Handle
Metal shaft
Base
Anchor
Figure 3. Anchor dispenser tool with the anchor.
6.
Thread the connector end of the lead into the metal shaft of the anchor dispenser tool
until the lead exits past the handle and through the slot (Figure 4).
Anchor
Lead
Handle
Slot
Thread lead through metal shaft
Lead
Figure 4. Threading the lead through the metal shaft.
7.
With one hand, grasp a portion of the lead that exited the slot, and with the other
hand, gently advance the anchor dispenser tool until the anchor is at the anchoring
site. Use care to maintain lead position.
977A1, 977A2 series 2019-10-01 English 17
Cautions:
The anchoring site should be as close as possible to where the lead
▪
emerges from the fascia. Anchors not secured to the ligament or fascia in
the anchor site may result in lead migration.
Do not use medical adhesives with the anchors in this kit. Medical adhesives
▪
may not provide sufficient anchoring strength, resulting in lead migration.
Notes:
If desired, embed the distal tip of the anchor into the anchor site tissue.
▪
Lubricants (eg, sterile water) are not required for anchor placement using the
▪
anchor dispenser tool.
8.
Use fluoroscopy to verify lead location.
9.
While maintaining lead position with one hand, position the fingers and thumb of the
other hand on the anchor dispenser tool similar to holding a syringe (Figure 5).
To release the anchor, use the fingers to pull the handle of the anchor dispenser tool
towards the thumb. The anchor will slide off the metal shaft onto the lead.
Note:
If the lead or anchor is not dry—after releasing the anchor, maintain lead
position for at least 15 seconds to allow for anchor compression and adequate
retention on the lead.
18 English 977A1, 977A2 series 2019-10-01
Hold the thumb steady
Use the fingers to pull the handle back
Lead
Anchor
Figure 5. Releasing the anchor.
10.
Grasp the lead near the anchor and use your other hand to gently slide the anchor
dispenser tool off from the end of the lead.
Note:
If the anchor needs to be removed, use the anchor removal tool. Refer to
"Removing an anchor from the lead" on page 21.
11.
Tie two or more ligatures to secure the anchor to the ligament or fascia using the
suture material prepared in step 4.
Warning
: Do not tie ligatures directly around the lead body. Ligatures around
the lead body can damage the lead body or conductor wires, resulting in a loss
of therapy. During an MRI scan, the patient could be at risk of tissue heating,
resulting in tissue damage or serious patient injury.
Cautions:
Do not use polypropylene suture material on silicone components.
▪
Polypropylene may damage the component, resulting in component failure.
Do not overtighten ligatures on the anchor or connector boot. Ligatures that
▪
are too tight may damage the component.
977A1, 977A2 series 2019-10-01 English 19
12.
While maintaining lead position, create a strain-relief loop with the lead body near the
secured anchor (Figure 6).
Lead electrodes
Anchor
Figure 6. Strain-relief loop made with the lead body.
Cautions:
Do not pull the lead or extension taut. Allow enough slack in the lead or
▪
extension to accommodate patient movement. Pulling the lead or extension
taut may result in a short or open circuit or migration of implanted
components.
Coil the excess lead body into a circular loop greater than 2 cm (0.8 in) in
▪
diameter. Do not use a U-shaped loop or bend (Figure 7). A circular loop
decreases the possibility of electromagnetic interference and its effects and
prevents kinking or damaging the lead body.
Figure 7. Coiling excess lead.
13.
Ensure that the lead has not moved during the anchoring process. If the lead has
moved, reestablish paresthesia coverage using program settings or minor lead
repositioning as required.
Notes:
For lead repositioning, refer to "Placing a percutaneous lead" on page 13.
▪
Neurostimulator
Strain-relief
loop
≥ 2 cm
20 English 977A1, 977A2 series 2019-10-01
If lead placement is for a trial and not for system implant, go to "Appendix: Trial
▪
procedures" on page 26 and continue from there.
Removing an anchor from the lead
An anchor removal tool is provided in the 97791 Injex Bumpy Anchor Accessory Kit.
If an anchor must be removed from the lead, proceed as follows:
1.
Cut any suture material that is securing the anchor.
2.
If necessary, expose the embedded anchor tip.
3.
Locate the anchor removal tool (Figure 8).
Handle
Slitting blade
Lead electrodes
Wide end of track
Side view End view
Figure 8. Anchor removal tool.
4.
Position the anchor removal tool near the anchor with the slitting blade facing in the
direction of the lead electrodes and the bottom of the track aligned with the lead body.
5.
Starting at the wide end of the track (opposite the slitting blade), slide a finger along
the underneath side of the lead to press the lead into the track (Figure 9).
977A1, 977A2 series 2019-10-01 English 21
Opening at bottom
of track
Anchor removal tool
Lead electrodes
Anchor
Figure 9. Anchor removal tool placement on the lead.
6.
While holding the lead with one hand, use the other hand to push the anchor removal
tool about one-half to two-thirds of the way through the anchor. Take care not to
disrupt lead placement.
Keep the top of the anchor removal tool handle parallel with the anchor axis when
▪
slitting the anchor wall.
Caution:
Do not hold the anchor removal tool at a sharp angle and then use
excessive force to push the tool through the anchor. Using a sharp angle and
excessive force at the same time could result in dislodgement of the lead and/or
damage to the lead or anchor removal tool. Dislodgement of or damage to the
lead may require additional surgery to restore therapy.
Do not pull back on the lead to create counter tension. Pulling on the lead may
▪
dislodge it.
7.
Push the anchor removal tool through the remainder of the anchor, while using the
forceps to grasp a slit segment of the anchor, if needed (Figure 10).
Place the lead body in the track
starting at the wide end
Lead
22 English 977A1, 977A2 series 2019-10-01
Anchor removal tool
Anchor
Lead
Hemostatic forceps
Figure 10. Using a grasping tool during anchor removal.
8.
Gently remove the anchor removal tool.
9.
Remove any remaining suture material that was securing the anchor.
10.
Gently remove the anchor from the lead.
11.
Inspect the lead for any damage near the anchor site.
12.
Discard the anchor and anchor removal tool after the anchor has been removed from
the lead.
13.
Use fluoroscopy to verify lead position.
Creating a subcutaneous pocket for the neurostimulator
Notes:
Refer to the neurostimulator implant manual for the proper subcutaneous pocket
▪
depth.
The neurostimulator should be placed on the opposite side of the body from another
▪
active implanted device and should be placed preferably on the right side of the body
to allow for future placement of cardiac devices on the patient's left side.
If a patient has a condition in the neurostimulator implant area that may require MRI
▪
scans, place the neurostimulator in another appropriate implant location to avoid
image distortion from the neurostimulator at the anatomy of interest during an MRI
scan.
1.
Choose a neurostimulator implant location in the buttocks, abdomen, or flank
(Figure 11) so that the patient will be full-body eligible for MRI scans.
977A1, 977A2 series 2019-10-01 English 23
Abdomen (anterior region
Buttocks
Figure 11. Neurostimulator implant locations for full-body MRI scan eligibility
2.
Make a small incision that will allow the neurostimulator to fit tightly in the
subcutaneous pocket.
3.
Use blunt dissection to create a subcutaneous pocket just large enough that the
neurostimulator and excess lead or extension coils fit tightly.
Caution
: To prevent device inversion, do not make the neurostimulator pocket
any larger than necessary to fit the neurostimulator and excess lead or
extension. Device inversion may result in component damage, lead
dislodgement, skin erosion, or stimulation at the implant site, requiring repeat
surgery to restore therapy.
between the lowest rib and pelvis)
Flank (lateral and posterior region
between the lowest rib and the pelvis)
Tunneling the lead for direct connection to a neurostimulator
1.
After simulating the tunneling route, mark the patient’s skin at the neurostimulator
pocket.
Cautions:
When routing the lead, avoid sharp bends or kinks, which may break the
▪
wires. Broken wires may create an open circuit, resulting in loss of
stimulation or component failure and requiring surgical replacement.
When multiple leads are implanted, route the leads so the area between
▪
them is minimized (Figure 12). If the leads are routed in a loop and the
patient is exposed to some sources of electromagnetic interference (eg, theft
detectors), the patient may perceive a momentary increase in stimulation,
which some patients have described as uncomfortable stimulation (jolting or
shocking sensation).
24 English 977A1, 977A2 series 2019-10-01
Proper
Improper
Figure 12. Routing for multiple leads.
2.
After assembling the tunneling tools, begin at the neurostimulator pocket and tunnel
subcutaneously to the lead incision site.
Caution:
Proceed slowly when the tunneling tool approaches the lead site. If
excess force is used, the patient could experience additional trauma when
resistance to tunneling suddenly ceases.
Notes:
Deep tunneling is not desirable.
▪
Avoid the lower thoracic ribs.
▪
If the tunneling tool does not extend to the lead incision site, make an
▪
intermediate incision.
3.
Unscrew the tunneling tip; then, remove the tunneling tool, leaving the passing straw
in place in the tunnel.
4.
Gently insert the proximal (connector) end of the lead through the passing straw to
the neurostimulator pocket.
5.
After carefully removing the passing straw, verify that the location of the lead has not
changed.
6.
Refer to the neurostimulator implant manual for instructions on connecting the lead to
the neurostimulator.
977A1, 977A2 series 2019-10-01 English 25
Appendix: Trial procedures
If these leads were implanted for a trial:
A 1x8 extension kit is required.
▪
The extension connects to the external devices (for example, external neurostimulator
▪
or trialing cable) for the trial period to ensure that lead sterility is not compromised.
The lead length chosen for the trial should be sufficient for direct connection to the
▪
neurostimulator at system implant.
Record the lead models and tip locations for use at system implant to ensure that MRI
▪
scan eligibility is accurate.
Perform the procedures in "Preparing for surgery" on page 13 through "Anchoring the
▪
lead and creating strain-relief loops" on page 16.
Note:
Use the procedure "Removing an anchor from the lead" on page 21 only if needed.
Warning
: Physicians should not prescribe MRI for patients undergoing a trial or test
stimulation period, or who have any neurostimulation system components that are not
fully implanted. Explant all trial components if an MRI scan is required. MRI has not
been tested on trial components and may cause heating of the lead electrodes,
resulting in tissue damage or serious patient injury.
Warning
: Do not tie ligatures directly around the lead body. Ligatures around the lead
body can damage the lead body or conductor wires, resulting in a loss of therapy.
During an MRI scan, the patient could be at risk of tissue heating, resulting in tissue
damage or serious patient injury.
Tunneling the percutaneous extension for the trial
1.
Use blunt dissection to create a small, subcutaneous pocket for the lead-extension
connection.
Note:
Ensure that the pocket is large enough to accommodate the lead-extension
connection and excess, coiled lead length.
2.
After simulating a tunneling route, mark the patient's skin at the lead-extension
connection pocket and at the percutaneous extension exit site (exit site). The exit site
should avoid the intended neurostimulator pocket site and be at least 10 cm (4.0 in)
lateral to the lead-extension connection pocket.
3.
After assembling the tunneling tools, make an incision at the exit site.
4.
Begin at the exit site and tunnel subcutaneously to the pocket.
Notes:
Deep tunneling is not desirable.
▪
Avoid the lower thoracic ribs.
▪
5.
Unscrew the tunneling tip; then, remove the tunneling tool, leaving the passing straw
in place in the tunnel.
6.
Gently insert the proximal end of the extension (ie, the end that will be externalized)
through the passing straw from the pocket to the exit site.
26 English 977A1, 977A2 series 2019-10-01
Connecting the percutaneous extension to the lead and closing the incision for the trial
Caution:
Before connecting components, wipe off any body fluids and dry all
connections. Fluids in the connection may result in stimulation at the connection site,
intermittent stimulation, or loss of stimulation.
1.
Slip the narrow end of the connector boot onto the lead body with the open end of the
connector boot facing outward, exposing the lead contacts.
Notes:
Irrigate the connector boot with a nonionic antibiotic solution. Dry the interior of
▪
the boot.
A clear and white radiopaque boot are provided in the extension kit for
▪
distinguishing the leads in two-lead implants.
2.
Wipe the lead body and extension setscrew connector junction with sterile gauze. If
necessary, use sterile (USP) water or a nonionic antibiotic solution. Dry all
connections.
3.
Insert the lead connector fully into the extension setscrew connector junction.
Notes:
Each lead contact must be aligned under each extension connector contact.
▪
During insertion, some resistance is typical.
▪
4.
Use the torque wrench from the extension kit to tighten the setscrew, which
completes the electrical circuit with the lead contacts.
Cautions:
To avoid overtightening, do not use a hex wrench to tighten an extension
▪
setscrew. Overtightening an extension setscrew may damage the lead
contacts and cause an open or short circuit, resulting in intermittent or loss
of stimulation.
Discard the torque wrench after making all connections. Reusing a torque
▪
wrench may result in undertightening or overtightening and subsequently,
intermittent or loss of stimulation.
5.
Carefully pull the proximal end of the extension (ie, the end that will be externalized)
through the tunnel to the exit site.
6.
Carefully remove the passing straw from the tunnel.
7.
Connect the proximal (externalized) end of the percutaneous extension to the external
device(s) used for checking impedances.
Refer to the instructions associated with the external device(s) for connection
information.
8.
Confirm the integrity of the lead-extension connection by checking the impedance of
all electrode pairs with the clinician programmer, then disconnect the external
device(s).
977A1, 977A2 series 2019-10-01 English 27
9.
After sliding the connector boot over the lead-extension connection, tie a ligature
between the rings on the wide end of the connector boot.
10.
Insert the coiled lead body in the lead-extension connection pocket, under the
connection, leaving as much slack as possible in the lead body between the anchor
and the lead-extension connection.
Cautions:
Do not pull the lead or extension taut. Allow enough slack in the lead or
▪
extension to accommodate patient movement. Pulling the lead or extension
taut may result in a short or open circuit or migration of implanted
components.
Coil the excess lead body into a circular loop greater than 2 cm (0.8 in) in
▪
diameter. Do not use a U-shaped loop or bend (Figure 13). A circular loop
decreases the possibility of electromagnetic interference and its effects and
prevents kinking or damaging the lead body.
≥ 2 cm
Figure 13. Coiling excess lead.
11.
Close the lead incision, coiling the percutaneous extension under a dressing with the
connector contacts exiting the bandage.
Preparing components for the trial
The patient’s response to the system and the efficacy of the system should be evaluated in
both a clinical and a home setting. Different electrode configurations should be evaluated at
various parameter settings during the trial period.
1.
Place a gauze bandage on the skin where the extension and external device(s) used
for the trial will be placed on the patient.
2.
Use the settings from "Testing stimulation intraoperatively" on page 15 to program the
external neurostimulator for the trial.
3.
Tape the extension and the external device(s) together to secure the connection.
4.
Tape the entire assembly to the patient's skin, allowing for strain relief.
5.
Proceed with the trial.
28 English 977A1, 977A2 series 2019-10-01
Removing the percutaneous extension after the trial
1.
Refer to the instructions associated with the external device(s) to disconnect the
device(s) from the percutaneous extension(s).
2.
Using minimal traction, pull the percutaneous extension until approximately 1 to 2 cm
(0.4 to 0.8 in) of the extension body is exposed from under the skin.
Caution:
When severing the percutaneous extension, use minimal traction on
the extension because strong force may dislodge the lead.
3.
Use sterile scissors to cut the exposed segment of the extension and allow the
implanted part of the extension to retract under the skin.
4.
Repeat steps 2 and 3 for the second extension, if applicable.
5.
Discard the severed part of the percutaneous extension.
6.
To remove the remaining segment of the percutaneous extension, find and expose
the lead-extension connection, then make an incision large enough to grasp the lead
body while maintaining lead position.
Notes:
Blunt dissection may be needed to expose the lead-extension connection.
▪
Use care to avoid damaging the coiled lead body in the pocket site.
▪
7.
While maintaining lead position, carefully remove the lead-extension connection from
the incision.
8.
Disconnect the lead from the percutaneous extension:
a. Remove the ligature, then slip the connector boot off the connection.
Caution:
Do not use sharp instruments near the lead. Nicking or cutting the
insulation may cause loss of stimulation or component failure requiring
surgical replacement.
b. Use the torque wrench from the INS kit to loosen the setscrew by turning the
wrench counterclockwise.
c. Gently separate the extension setscrew connector from the lead.
Caution:
If resistance is felt while removing the lead from the extension
connector, first, loosen (but do not remove) the setscrews to ensure the lead
contacts are not engaged. Next, inspect the lead connector for damage (eg,
flattening of the lead contacts, stretching of the lead), which may result in
intermittent or loss of stimulation.
d. Remove and discard the connector boot; if necessary, carefully slit the boot.
9.
Remove and discard the remaining segment of the percutaneous extension.
10.
For a second percutaneous extension, repeat steps 6 to 9.
11.
If proceeding with system implant, refer to "Creating a subcutaneous pocket for the
neurostimulator" on page 23.
977A1, 977A2 series 2019-10-01 English 29
Manufacturer
Medtronic, Inc.
710 Medtronic Parkway,
Minneapolis, MN 55432-5604,
USA
www.medtronic.com
Tel. +1-763-505-5000
REP
Authorized Representative
in the European Community
Medtronic B.V.
Earl Bakkenstraat 10,
6422 PJ Heerlen,
The Netherlands
Tel. +31-45-566-8000
Europe/Africa/Middle East Headquarters
Medtronic International Trading Sàrl
Route du Molliau 31,
Case Postale 84
CH - 1131 Tolochenaz,
Switzerland
www.medtronic.eu
Tel. +41-21-802-7000
Asia-Pacific
Medtronic International Ltd.
50 Pasir Panjang Road,
#04-51 Mapletree Business City,
Singapore 117384,
Singapore
Tel. +65-6870-5510
EC
*M939859A011*
© Medtronic 2019
All Rights Reserved
2019-10-01
M939859A011 Rev A
Loading...