St. Jude Medical 8-Channel Adapter Clinician's Manual
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. For U.S. California Only: Proposition 65, a State of California voter initiative, requires the following notice: WARNING: This product contains a chemical known to the State of California to cause cancer and birth defects or other reproductive harm. Unless otherwise noted, indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies. Pat. http://patents.sjm.com 2016 St. Jude Medical, Inc. All Rights Reserved.
Contents Prescription and Safety Information... 1 Intended Use... 1 Additional Prescription Information... 1 Warnings... 1 Precautions... 2 Compatibility... 4 Considerations for Use... 6 Product Description... 7 Package Contents... 8 Disconnecting the Existing Generator... 8 Determining Adapter Compatibility... 9 Connecting the Adapter to the Existing Lead or Extension... 10 Using the Adapter with a Second Pocket... 12 Connecting the St. Jude Medical IPG to the Adapter... 13 Placing the Adapter and IPG in the Pocket and Closing the Pocket... 14 i
Using the Adapter with a Trial System... 15 Limited Warranty... 16 Technical Support... 16 Appendix A: Product Specifications... 17 St. Jude Medical 8-Channel Adapter... 17 Appendix B: Symbols and Definitions... 18 ii
Prescription and Safety Information Read this section to gather important prescription and safety information. Intended Use The St. Jude Medical 8-Channel Adapter is designed to connect a non St. Jude Medical implanted neurostimulation lead or extension to an 8-channel port of a St. Jude Medical implantable pulse generator (IPG) system or St. Jude Medical trial system. Additional Prescription Information For information about other parts of your neurostimulation system, including indications for use, contraindications, and potential adverse effects, refer to the clinician s manual for the appropriate device. Warnings The following warnings apply to these components. Other system components. Refer to the individual system component manuals for additional warnings and precautions related to those devices. Poor surgical risks. Neurostimulation devices should not be implanted in patients who are poor surgical risks or patients with multiple illnesses or active general infections. 1
Device components. The use of components not approved by St. Jude Medical with this device may result in damage to the device and increased risk to the patient. Device modification. Do not modify the device in any way, such as by cutting it or altering its shape. Anticoagulants. Physicians should use extreme care with lead implantation in patients with a heightened risk of hemorrhage. Physicians should also consider underlying factors, such as previous injury or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding. Precautions The following precautions apply to these components. General Precautions Physician training. Implanting physicians should be experienced in implanting neurostimulation devices and should have undergone sufficient surgical and device implantation training. Patient selection. It is extremely important to select patients appropriately for neurostimulation. Patients should be able to operate the stimulator. Infection. It is important to follow proper infection control procedures. Infections related to device implantation might require that the device be explanted. Sterilization and Storage Single use only. Implantable components are intended for single use only. Sterile components in this 2
kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in the sterile packaging to permit direct introduction into the operative field. Do not resterilize or reimplant them because of the risk of infection. Exposure to liquids. Device components should be stored where they will not be exposed to liquids or excessive moisture, which can damage the seal integrity of the package materials. Handling and Implementation Expiration date. An expiration date (or "use-before" date) is printed on the packaging. Do not use a component if the use-before date has expired. Package or component damage. Do not implant the device if the sterile package or components show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any reason. Return any suspect components to St. Jude Medical for evaluation. Exposure to body fluids or saline. Exposure of the internal metal (i.e., contacts on the lead or extension) to body fluids or saline can cause corrosion and affect stimulation. If this occurs, clean with sterile deionized water or sterile water for irrigation and dry completely prior to lead or extension connection and implantation. Use of adhesives. To keep the device functioning correctly, do not use adhesives. Device testing. The operation of the device should always be tested after implantation and before the patient leaves the surgery suite to assure correct operation. Component disposal. Return all explanted components to St. Jude Medical for safe disposal. 3
Compatibility The St. Jude Medical 8-Channel Adapter (Models 2311 and 2316) is compatible with Medtronic lead and extension models available before August 31, 2014. (Medtronic is a trademark of Medtronic, Inc.) Table 1. Device compatibility (Medtronic) Device Model Number Permanent Lead 3776-45, 3776-60, 3776-75, 3876-45, 3876-60, 3876-75, 3777-45, 3777-60, 3777-75, 3877-45, 3877-60, 3877-75, 3778-45, 3778-60, 3778-75, 3878-45, 3878-60, 3878-75, 39286-30, 39286-65, 39565-30, 39565-65 Extension 3708120, 3708140, 3708160, 3708220, 3708240, 3708260, 3708320, 3708340, 3708360, 3876, 3877, 3878 Trial Lead 3873-45, 3873-60, 387445, 387460, 3875-45, 3875-60 DBS Extension* 37085-40, 37085-60, 37085-95, 37086-40, 37086-60, 37086-95 * The specified DBS extensions are connected to Medtronic DBS leads (Model 3387 or 3389) to ensure compatibility with the adapter. 4
The St. Jude Medical 8-Channel Adapter (Models 2321 and 2326) is compatible with Boston Scientific spinal cord stimulation lead and extension models available before August 31, 2014. (Boston Scientific is a trademark of Boston Scientific Scimed, Inc.) CAUTION: Only use this device with spinal cord stimulation systems. Do not use this device with other neuromodulation systems, such as deep brain stimulation systems. Table 2. Device compatibility (Boston Scientific) Device Permanent Lead Extension Trial Lead Model Number SC-2016-50, SC-2016-70, SC-2138-30, SC-2138-50, SC-2138-70, SC-2158-30, SC-2158-50, SC-2158-70, SC-2208-30, SC-2208-50, SC-2208-70, SC-2218-30, SC-2218-50, SC-2218-70, SC-2352-30, SC-2352-50, SC-2352-70, SC-2366-30, SC-2366-50, SC-2366-70, SC-2316-50, SC-2316-70, SC-8120-50, SC-8120-70, SC-8216-50, SC-8216-70 SC-3138-25, SC-3138-35, SC-3138-55, SC-3304-25, SC-3354-25, SC-3400-30 SC-2016-50E, SC-2016-70E, SC-2158-30E, SC-2158-50E, SC-2158-70E, SC-2218-30E, SC-2218-50E, SC-2218-70E, SC-2352-30E, SC-2352-50E, SC-2352-70E, SC-2366-30E, SC-2366-50E, SC-2366-70E, SC-2316-50E, SC-2316-70E 5
Considerations for Use When connecting a non St. Jude Medical lead or extension to a St. Jude Medical 8-channel port implantable pulse generator or St. Jude Medical trial system, implanting physicians must: Ensure the lead or extension meets the dimensional and functional specifications for which the St. Jude Medical 8-Channel Adapter is designed. Determine if the lead or extension design was modified. Use the sizing gauge card to ensure the lead or extension s terminal end is the specified dimension (see Determining Adapter Compatibility (page 9)). Reset all programming parameters to minimal values. Since design and function varies between different systems, the implanting physician must trial all programming parameters for the patient once the new system is implanted. 6
Product Description Use the St. Jude Medical 8-Channel Adapter to connect a non St. Jude Medical implanted lead or extension to an 8-channel port implantable pulse generator system or trial system. Refer to the following figure for the adapter features. NOTE: The figures in this manual are representations of the adapter. There are minor differences in the adapter due to compatibility with other devices, but the functionality remains the same. Figure 1. Adapter features 1. Adapter 2. Connector contacts 3. Insertion point for terminal end lead or extension 4. Setscrew 5. Adapter terminal end 7
Package Contents In addition to the product documentation, the adapter kit contains the following items: 1 adapter 1 sizing gauge card 1 torque wrench Disconnecting the Existing Generator 1. Carefully make an incision over the existing IPG pocket to expose the lead or extension and IPG. CAUTION: Use extreme care when cutting near the lead or extension to avoid damaging the implanted lead or extension. 2. After the IPG is removed, carefully disconnect the implanted lead or extension from the IPG. 3. Clean the contacts of the currently implanted lead or extension with sterile deionized or distilled water (not saline) and dry them completely with a sterile gauze sponge. CAUTION: Exposure of the contacts to body fluids or saline can cause corrosion and affect stimulation. If this occurs, clean the contacts with deionized or distilled sterile water and dry completely before connecting and implanting the lead or extension. 4. Visually check the terminal end of the lead or extension for damage. 8
Determining Adapter Compatibility 1. Using the sizing gauge card provided in the adapter kit, carefully insert the terminal end of the lead or extension into the hole at the top of the gauge. Check that the terminal end fits snugly into the gauge. NOTE: If the terminal end of the lead or extension does not fit into the top hole of the gauge or the fit is not snug, then the lead or extension is not the correct diameter for use with the adapter. NOTE: If the fit in the top hole is not snug then test the terminal end with the second hole (beneath the first hole). If the lead or extension fits into the second hole then the diameter is not correct for use with the adapter. 2. Place the terminal end of the lead or extension between the two sets of rectangles imprinted on the lower left hand corner of the card. Check that the connector bands align with the rectangles. NOTE: If the bands do not align with the rectangles on the sizing gauge card, the lead or extension is not the correct size for use with the adapter. 9
Figure 2. Sizing gauge card 1. First hole 2. Second hole 3. Rectangles Connecting the Adapter to the Existing Lead or Extension 1. Discard the explanted IPG appropriately. 2. Ensure the existing pocket is large enough for the lead or extension and adapter to fit without kinking. For instructions on using a second pocket, see Using the Adapter with a Second Pocket (page 12). 3. Clean the contacts of the currently implanted lead or extension with sterile deionized or distilled water (not saline) and dry them completely with a sterile gauze sponge. 10
4. Carefully place the terminal (proximal) end of the lead or extension into the adapter; do not sharply bend the lead or extension or the terminal end. 5. Gently push the terminal end of the lead or extension into the adapter until the tip encounters a hard stop. Visually confirm that the lead or extension contacts are fully inserted and align with the connector contacts. NOTE: Too much pressure may cause misalignment between the terminal contacts of the lead or extension and the metal connector contacts of the adapter. Figure 3. Inserting the lead or extension into the adapter 1. Lead or extension 2. Connector contacts 6. Secure the lead or extension by tightening the setscrew in the adapter with the calibrated torque wrench provided. Tighten the setscrew until you hear at least one click. NOTE: Do not use adhesives on the adapter. 11
Figure 4. Securing the lead or extension in the adapter Using the Adapter with a Second Pocket NOTE: For instructions on creating a second pocket, refer to the applicable St. Jude Medical IPG clinician's manual. NOTE: Do not move the lead or extension from the original pocket. 1. Connect the adapter to the lead or extension in the original pocket using the instructions in Connecting the Adapter to the Existing Lead or Extension (page 10). 12
2. Anchor the adapter in the original pocket using the instructions in the applicable St. Jude Medical component clinician's manual. 3. Close the original pocket and apply the appropriate dressings. 4. Tunnel to the new IPG site using the instructions in the applicable St. Jude Medical IPG clinician's manual. Connecting the St. Jude Medical IPG to the Adapter 1. Carefully place the adapter s terminal end into the St. Jude Medical IPG. Ensure all the contacts are placed fully into the connector and disappear from view. 2. Confirm visually that the adapter is fully inserted into the generator using the same instructions for connecting a lead or extension to the IPG as described in the applicable IPG clinician's manual. 3. Secure the adapter by tightening the setscrew in the septum with the calibrated torque wrench provided in the kit. NOTE: For additional instructions on connecting the St. Jude Medical IPG to the adapter, refer to the applicable St. Jude Medical IPG clinician's manual. Follow the instructions for connecting the extension to the IPG. 13
Placing the Adapter and IPG in the Pocket and Closing the Pocket 1. Coil any excess lead or extension behind the IPG; ensure the loop is no smaller than 2.5 cm (1 in). Figure 5. Placing the lead or extension, adapter, and IPG in the pocket 2. Place the excess lead or extension, adapter and IPG in the pocket. 3. Close and apply the appropriate dressings. 14
4. Follow the instructions for stimulation located in the applicable IPG clinician s manual. Using the Adapter with a Trial System 1. Carefully disconnect the implanted lead from the non-st. Jude Medical trial system. 2. Visually check the terminal end of the lead for damage. 3. Use the sizing gauge card to ensure the lead s terminal end is the specified dimension. See Determining Adapter Compatibility (page 4). 4. Connect the adapter to the lead using the applicable instructions in Connecting the Adapter to the Existing Lead or Extension (page 10). 5. Follow the instructions in the applicable St. Jude Medical trial system clinician s manual for connecting the adapter to the trial system and programming stimulation for the trial period. 6. Secure the adapter to the patient along with the St. Jude Medical trial system using the instructions in the applicable clinician s manual. 15
Limited Warranty From the date of implant of the St. Jude Medical 8-Channel Adapter, St. Jude Medical will extend our standard one-year Limited Warranty on the St. Jude Medical adapter. For Limited Warranty covering the neurostimulator, refer to the appropriate manual. Technical Support For technical questions and support for your St. Jude Medical neuromodulation product, use the following information: +1 972 309 8000 +1 800 727 7846 (toll-free within North America) For additional assistance, call your local St. Jude Medical representative. 16
Appendix A: Product Specifications St. Jude Medical 8-Channel Adapter The following table lists adapter model numbers and physical specifications. Table 3. Adapter Specifications 10 cm 60 cm Adapter, M model # 2311 2316 Adapter, B model # 2321 2326 Storage temperature -10 C 55 C (14 F 131 F) Storage humidity 10% 90% (noncondensing) Storage pressure 70 150 kpa (10.2 21.8 psi) Length 4.3 cm (1.7 in) Height (max) 0.89 cm (0.35 in) Width (max) 0.89 cm (0.35 in) Weight 3.4 g (0.12 oz) 17
Table 3. Adapter Specifications Connector retention strength Spacing between electrodes 7.5N (M) 10N (B) 0.28 cm (0.11 in) Appendix B: Symbols and Definitions The following symbols may be used in this document and on some of the products and packaging: Table 4. Symbols and definitions Symbol Definition Caution, consult accompanying documents Consult instructions for use 18
Table 4. Symbols and definitions Symbol Definition Follow instructions for use on this website Single use only Do not resterilize Expiration date Date of manufacture Manufacturing facility Temperature limits for storage conditions 19
Table 4. Symbols and definitions Symbol Definition Humidity limits Pressure limits Do not use if the product sterilization barrier or its packaging is compromised Catalog number Manufacturer Contents quantity One lead 20
Table 4. Symbols and definitions Symbol Definition Accessories Serial number Batch code Prescription use only Ethylene oxide gas sterilization Authorized European representative 21
Table 4. Symbols and definitions Symbol Definition This product shall not be treated as household waste. Instead it is the user s responsibility to return this product to St. Jude Medical for reprocessing. By ensuring that this product is disposed of properly, you will help prevent potential negative consequences for the environment and human health, which could be caused by inappropriate waste handling of this product. The recycling of materials will help to conserve natural resources. For more information about how to return this product for recycling, please contact St. Jude Medical. European conformity, affixed in accordance with the relevant provisions of AIMD directive 90/385/EEC. Hereby, St. Jude Medical declares that this device is in compliance with the essential requirements and other relevant provisions of this directive. 22
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