Medtronic 8540 Instructions for Use

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Catheter Access Port Kits 8540

for use with Medtronic Implantable Infusion Pumps

8543

Instructions for Use

Rx only

1993 (8540) 1997 (8543)

Explanation of symbols on product or package labeling

Refer to the appropriate product for symbols that apply.

Open here

Do not reuse

Sterilized using ethylene oxide

-XX °C

-XX °F

! USA

XXX °F

LOT

REP

Consult instructions for use

Use by

Date of manufacture

Manufacturer

XX °C

Temperature limitation

Lot number

Authorized representative in the European community

Volume

Conformité Européenne (European Conformity). This symbol means that the device fully complies with European Directive AIMD 90/385/EEC.

For USA audiences only

STERILE

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Medtronic, IsoMed, SynchroMed, and Medtronic logo are trademarks of Medtronic.

MiniMed® is a registered trademark of Medtronic MiniMed, Inc.

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Introduction 7

Package contents 7

Indications 7

Contraindications 7

Warnings 7

Precautions 9

Adverse events 11

Instructions for Use 11

Preliminary procedures 11 Preparing the access site 11 Intraspinal applications only 12 Vascular applications only 13 Flushing the catheter access port 14 Clearing a catheter occlusion 14

Technical support 15

Emergency procedures 16

Baclofen injection overdose 16 Baclofen injection underdose/withdrawal 18 Morphine intrathecal/epidural overdose 20 Emergency procedure to empty pump reservoir 22

Special notice 23

Limited Warranty 24

Medtronic® Neuromodulation MODEL 8540 AND MODEL 8543 CATHETER ACCESS PORT KITS LIMITED WARRANTY (U.S. Customers Only) 24

Refer to the Indications, Drug Stability, and Emergency Procedures reference manual for indications and related information.

Refer to the appropriate information for prescribers booklet for contraindications, warnings, precautions, adverse events summary, individualization of treatment, patient selection, use in specific populations, and component disposal.

Refer to the appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration information, and screening procedures.

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Introduction

These instructions include only the procedure for accessing the catheter via the catheter access port. Refer to the appropriate pump technical manual for implanting instructions and pump indications, contraindications, warnings, precautions, and adverse events.

Package contents

The Model 8540 Catheter Access Port Kit (CAP kit) contains the following sterile components that are not made with natural rubber latex:

Extension set with a clamp

▪

0.22-micron filter

▪

24-gauge noncoring needles with purple color (2)

▪

25-gauge noncoring needles with orange color (2)

▪

10-mL syringe

▪

Fenestrated drape

▪

Template (2)

▪

The Model 8543 Catheter Access Port Kit (CAP kit) contains the following sterile components that are not made with natural rubber latex:

Extension set with a clamp

▪

0.22-micron filter

▪

24-gauge noncoring needles with purple color (2)

▪

10-mL syringe

▪

Fenestrated drape

▪

Template (1)

▪

Indications

The Model 8540 Catheter Access Port Kit is intended for use in accessing the catheter via the catheter access port of Medtronic implantable programmable infusion pumps (except Medtronic MiniMed pumps).

The Model 8543 Catheter Access Port Kit is intended for use in accessing the catheter via the catheter access port of Medtronic implantable IsoMed pumps.

Contraindications

Medtronic catheter access port kits are contraindicated for all refill procedures. Blood sampling through the catheter access port is contraindicated. Blood sampling can occlude the catheter or pump, inhibiting drug delivery and requiring surgical revision or replacement.

Warnings

Advancing drug to catheter tip (intraspinal applications) - For intraspinal

applications, do not inject drug directly into the catheter or through the catheter access port to advance drug to the catheter tip. Injecting through the catheter access port or injecting directly into the catheter to advance drug to the catheter tip can result in a clinically significant or fatal drug overdose.

Calculating catheter volume - Use the catheter length recorded at implant or catheter revision when calculating catheter volume. The actual implanted catheter length and catheter model number are required to accurately calculate catheter volume. A universal value does not exist that can be used as a substitute for this knowledge. An inaccurate catheter volume calculation can result in a clinically significant or fatal drug underdose or overdose.

Catheter access port kit components - The appropriate Medtronic catheter access port kit MUST be used during all catheter access port procedures for Medtronic implantable infusion pumps. Using components other than

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Medtronic components or a kit other than the appropriate catheter access port kit can damage Medtronic components, requiring surgical revision or replacement, and allow drug leakage into surrounding tissue, resulting in tissue damage or loss of or change in therapy, which may lead to a return of underlying symptoms, drug withdrawal symptoms, or a clinically significant or fatal drug underdose.

Catheter aspiration (intraspinal applications) - During intraspinal applications, before injecting fluids through the catheter access port, aspirate approximately 1 to 2 mL from the catheter (unless contraindicated). A significant amount of drug may be present in the catheter access port and catheter, and failure to remove the drug during catheter access port injections can result in a clinically significant or fatal drug overdose.

Catheter aspiration (vascular applications) - During vascular applications, do not aspirate blood through the catheter access port or catheter. Blood sampling or aspiration through the catheter access port is contraindicated in vascular applications. Residual blood from aspiration or blood sampling can occlude the catheter or pump and inhibit drug delivery, resulting in a loss of or change in therapy, which may lead to a return of underlying symptoms, drug withdrawal symptoms, or a clinically significant or fatal drug underdose, and require surgical revision or replacement.

Connections - Firmly secure all connections. Failure to secure connections can allow drug to leak onto the surrounding skin and may result in inadequate therapy or infection.

Contrast medium - When injecting contrast medium into the intraspinal space, use ONLY contrast medium indicated for intraspinal use. Using nonindicated contrast media can result in adverse events including, but not limited to, extreme pain, cramps, seizures, and death. Inject contrast medium through the catheter access port only.

Drug information - Refer to the appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration information, and screening procedures. Refer to the appropriate drug labeling for specific drug underdose or overdose symptoms and methods of management. Failure to refer to the drug labeling can result in inappropriate patient selection and management, inadequate therapy, intolerable side effects, or a clinically significant or fatal drug underdose or overdose. Consider the possibility of a drug error if the patient experiences unusual side effects. Failure to do so can result in misdiagnosis of patient symptoms.

Drug interaction and side effects - Inform patients of the appropriate warnings and precautions regarding drug interactions, potential side effects, and signs and symptoms that require medical attention, including prodromal signs and symptoms of inflammatory mass. Failure to recognize the signs and symptoms and to seek appropriate medical intervention can result in serious patient injury or death.

Drug overdose symptoms and management - Refer to the emergency procedures included at the end of this manual and the appropriate drug labeling for specific drug overdose symptoms and methods of management.

Drug underdose/overdose - Inform patients and caregivers of the signs and symptoms of a drug underdose and overdose. Inform patients and caregivers:

to be aware and report any unusual signs or symptoms at any time

▪

during or after a refill or catheter access port procedure. to be alert for any burning sensations in the area of the pump pocket

▪

during their refill or catheter access port procedure. to especially watch for signs of underdose and overdose.

▪

to stay alert for signs or symptoms that may indicate changes to their

▪

prescribed drug concentration or programmed dose. to seek emergency assistance as necessary. Refer to the refill kit or

▪

CAP kit manual or the Indications, Drug Stability and Emergency Procedures for SynchroMed and IsoMed Implantable Infusion Systems Reference Manual for emergency procedures associated with drug underdose and overdose.

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Failure to recognize these signs and symptoms and to seek appropriate medical intervention can result in serious patient injury or death.

Implantation and system management - Implantation and ongoing system management must be performed by individuals trained in the operation and handling of the infusion system and must be in compliance with procedures described in the appropriate technical instructions. Inadequate training or failure to follow instructions can require surgical revision or replacement, and result in a clinically significant or fatal drug underdose or overdose.

Injection error during a catheter access port procedure - Be certain you are accessing the correct port when injecting fluids into the catheter access port of an implanted pump. ALWAYS:

identify the pump model.

▪

identify the location of the catheter access port.

▪

use the instructions, noncoring needles, appropriate template, and

▪

other accessories provided in the appropriate kit. verify the location of the correct port during needle insertion according

▪

to the instructions provided AND using other medical procedures as appropriate.

refer to the appropriate drug labeling for indications, contraindications,

▪

warnings, precautions, adverse events, and dosage and

administration information. Pocket fill is the improper injection into the subcutaneous tissue, which includes the pump pocket, during a catheter access port injection. Pocket fill can result in significant tissue damage or a loss of or change in symptom control, drug withdrawal symptoms, or a clinically significant or fatal drug underdose or overdose. Observe the patient after the catheter access port injection for any signs or symptoms that could indicate a pocket fill or any other drug-related adverse event. Seek emergency assistance as necessary. Refer to the CAP kit manual or the Indications, Drug Stability and Emergency Procedures for SynchroMed and IsoMed Implantable Infusion Systems Reference Manual for emergency procedures associated with drug underdose and overdose.

Inadvertent injection into the reservoir fill port can result in changes to the drug concentration and drug content in the pump reservoir, resulting in a clinically significant or fatal drug underdose or overdose. Injection of fluids such as contrast media into the reservoir fill port may result in permanent system damage leading to a clinically significant or fatal drug underdose or overdose.

Intraspinal therapy - For intraspinal therapy, use ONLY a preservative-free sterile solution indicated for intraspinal use. Nonindicated fluids containing preservatives or endotoxins can be neurotoxic in intraspinal applications. Using nonindicated fluids can result in adverse events including, but not limited to, extreme pain, cramps, seizures, and death.

User instructions - Comply with all product instructions for initial preparation and filling, implantation, programming (if applicable), refilling, and accessing the catheter access port (if present) of the pump. Failure to comply with all instructions can lead to technical errors or improper use of implanted infusion pumps and result in additional surgical procedures, a return of underlying symptoms, drug withdrawal symptoms, or a clinically significant or fatal drug underdose or overdose.

Precautions

Aseptic technique - Use strict aseptic technique when accessing the

reservoir fill port or the catheter access port of an implanted pump. Failure to use aseptic technique can contaminate fluids or tissues and result in local or systemic infection.

Catheter access port filter - Always use a bacterial-retentive filter when injecting through the catheter access port. The catheter access port does not contain a filter. Injecting into the catheter without using a filter can contaminate fluids or tissues and result in local or systemic infection.

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Catheter access port injections - Do not use excessive force, do not use syringes smaller than 10 mL and do not rock the needle sideways when accessing the catheter access port. Using excessive force or syringes smaller than 10 mL can cause the catheter to detach or rupture, resulting in leakage into tissue, into the pump pocket, or along the catheter track. Rocking can break the needle, resulting in leakage into tissue or pump pocket or needle fragments lodging in the patient and requiring surgical revision or replacement of the pump or additional surgery to remove needle fragments from the patient.

Catheter patency (vascular applications) - When using a nonheparinized solution in vascular applications, flush the catheter through the catheter access port after every use and/or at a minimum of once per month to maintain the patency of the catheter. Failure to maintain catheter patency increases the likelihood of a catheter occlusion that can inhibit drug delivery, resulting in a loss of or change in therapy, which may lead to a return of underlying symptoms. If catheter occlusion is suspected, follow the instructions for clearing a catheter occlusion in the catheter access port kit manual.

For programmable pumps, continuous modes are recommended for vascular applications to maintain catheter patency. Because of insufficient flow through the catheter to maintain catheter patency, bolus modes are not recommended for vascular applications, except under conditions of close supervision.

Catheter tip occlusion (vascular applications only) - Follow the instructions in "Clearing a Catheter Occlusion". Catheter tip occlusions can inhibit drug delivery, requiring surgical revision or replacement of the catheter.

Compatibility, all components - Follow these guidelines when selecting system components:

Medtronic components: For proper therapy, use only components

▪

that are compatible with the appropriate indication. Non-Medtronic components: No claims of safety, efficacy, or

▪

compatibility are made with regard to the use of non-Medtronic components with Medtronic components. Refer to the non-Medtronic documentation for information.

Component packaging - Before shipment the components in the sterile package were sterilized by the process indicated on the package label. Do not use or implant a component if the following circumstances have occurred:

The storage package or sterile seal has been pierced or altered

▪

because component sterility cannot be guaranteed and infection may occur.

The component shows signs of damage because the component may

▪

not function properly. The use-by date has expired because component sterility cannot be

▪

guaranteed and infection may occur; also, device battery longevity may be reduced and may require early replacement.

Infection - Use extreme caution when accessing the reservoir fill port or catheter access port of the implanted pump if local or systemic infection is suspected. Avoid contaminating the system or further spreading the infection. Local or systemic infection may require pump revision or removal.

Single use only - Do not reuse any component. Components are intended for single use only. Reusing components can result in inadequate therapy and an increased risk of infection.

Storage temperature: kits and accessories - Do not store or transport the kit device components or accessories above 57 °C (135 °F) or below –34 °C (–30 °F). Temperatures outside this range can damage device components.

Vesicant drug (vascular applications) - Do not spill or leak vesicant or cytotoxic drug into adjacent tissue during pump procedures. Spillage or leakage of vesicant drug into adjacent tissue can result in significant local tissue damage.

Vesicant/cytotoxic drugs at implant - Do not spill or leak vesicant or cytotoxic drug into adjacent tissue during pump procedures. Spillage or

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leakage of vesicant drug into adjacent tissue can result in significant local tissue damage. If the drug to be used is a vesicant or has the potential to cause local tissue damage, do not put the drug into the pump until after implantation. Fill the pump and catheter with saline (a heparinized solution may be used if not contraindicated) instead of the drug.

Adverse events

The adverse events associated with the use of this device may include, but may not be limited to, the following:

Meningitis (intraspinal applications)

▪

Infection

▪

Injection into pocket or subcutaneous tissue

▪

Instructions for Use

Become thoroughly familiar with all product literature before using catheter access port kits.

Sterilization

All components of the kit are sterile. Do not resterilize. Should sterility of the kit be in question, discard and use a new kit.

Preliminary procedures

1. Gather the following sterile equipment:

For programmable pumps, from the Model 8540 Catheter Access Port Kit:

Extension set with clamp

▪

0.22-micron filter

▪

10-mL empty syringe (for aspirating in intraspinal applications)

▪

Fenestrated drape

▪

Appropriate template and noncoring needle

▪

For IsoMed pumps, the Model 8543 Catheter Access Port Kit:

Extension set with clamp

▪

0.22-micron filter

▪

10-mL empty syringe (for aspirating in intraspinal applications)

▪

Fenestrated drape

▪

24-gauge noncoring needle

▪

Template

▪

Note: The template and needle are pump-specific. Match the name on the template with the name of the pump. Match the color and gauge of the needle to the color and gauge indicated on the template (purple for IsoMed and SynchroMed II pumps; orange for SynchroMed EL pumps). If you are unsure of which pump is implanted, consult the patient’s record.

Locally supplied:

Syringe containing prescribed fluid (10-mL syringe minimum)

▪

Syringe with 5 mL saline (for flushing if desired)

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Cleansing agent

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Sterile gloves

▪

Alcohol pads or swabs

▪

Adhesive bandage, optional

▪

2. For programmable pumps, prepare the programmer for use. Refer to the appropriate programming guide for instructions.

Preparing the access site

1. Identify the pump model, reservoir volume, and location of the catheter

access port.

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2. Prepare the injection site by cleansing the area.

3. Open the kit. Put on sterile gloves.

4. Place the drape, exposing the pump site.

5. Ensure that you plan to use the correct template for the patient’s

implanted pump, SynchroMed or IsoMed. If you are unsure of which pump is implanted, consult the patient’s record.

6. Place the correct pump template over the pump, aligning the edges of the template with the edges of the pump. Locate the catheter access port.

Intraspinal applications only

Warning: Pocket fill is the improper injection into the subcutaneous tissue, which

includes the pump pocket, during a catheter access port injection. Pocket fill can result in significant tissue damage or a loss of or change in symptom control, drug withdrawal symptoms, or a clinically significant or fatal drug underdose or overdose. Observe the patient after the catheter access port injection for any signs or symptoms that could indicate a pocket fill or any other drug-related adverse event.

1. Using sterile procedures, assemble the needle, extension set, and empty syringe (Figure 1).

2. Close the clamp and gently insert the needle into the catheter access port until the needle touches the needle stop (Figure 1).

Closed clamp

Extension set

Empty syringe

Te mp la t e

Needle

Catheter access port

Figure 1. Close the clamp and insert the needle into the catheter access

3. Open the clamp and aspirate approximately 1-2 mL to ensure removal of drug from the catheter access port and catheter. Refer to the specifications in the appropriate catheter technical manual for the catheter volume.

4. Close the clamp and remove the syringe. Note: Keep the needle in the catheter access port and the clamp closed

for the procedure that follows.

5. Purge the air from the syringe containing the prescribed fluid.

6. Attach the filter to the syringe with the prescribed fluid.

7. Purge all air from the filter.

8. Attach the syringe with the filter to the extension set (Figure 2).

9. Open the clamp and inject the drug at an infusion rate not greater than 5

mL per minute (Figure 2).

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port.

Te mp l at e

Open clamp

Syringe with prescribed fluid

Filter

Needle

Catheter access port

Figure 2. Open the clamp and inject into the catheter access port.

10. During injection, check the needle puncture site for swelling. Swelling may indicate that the needle tip is in the pump pocket and not in the catheter access port.

11. When the drug has been injected, close the clamp, and carefully remove the syringe.

12. Proceed to "Flushing the catheter access port" on page 14.

Extension set

Vascular applications only

Warning: Pocket fill is the improper injection into the subcutaneous tissue, which

Warning: During vascular applications, do not aspirate blood through the catheter access port or catheter. Blood sampling or aspiration through the catheter access port is contraindicated in vascular applications. Residual blood from aspiration or blood sampling can occlude the catheter or pump and inhibit drug delivery, resulting in a loss of or change in therapy, which may lead to a return of underlying symptoms, drug withdrawal symptoms, or a clinically significant or fatal drug underdose, and require surgical revision or replacement.

1. Using sterile procedures, assemble the needle, extension set, filter, and syringe containing the prescribed fluid.

2. Purge the air from the fluid pathway.

3. Close the clamp and gently insert the needle into the catheter access

port until the needle touches the needle stop.

4. Open the clamp and inject the drug at an infusion rate not greater than 5 mL per minute (Figure 2 on page 13). Note: If a catheter occlusion is suspected, refer to the instructions in "Clearing a catheter occlusion" on page 14.

5. During injection, check the needle puncture site for swelling. Swelling may indicate that the needle tip is in the pump pocket and not in the catheter access port.

6. When the drug has been injected, close the clamp, and carefully remove the syringe, leaving the filter attached to the extension set.

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7. Proceed to "Flushing the catheter access port".

Flushing the catheter access port

Warning: Pocket fill is the improper injection into the subcutaneous tissue, which

1. If flushing is desired, attach a syringe containing 5 mL of sterile saline to the extension set. Note: For vascular applications, use a heparinized solution (if not contraindicated). For intraspinal applications, use a preservative-free solution.

2. Open the clamp and inject directly at an infusion rate not greater than 5 mL per minute.

3. During injection, check the needle puncture site for swelling. Swelling may indicate that the needle tip is in the pump pocket and not in the catheter access port. Note: Flushing the catheter access port also flushes the drug from the catheter. Drug therapy from the pump will be lost until the catheter is refilled by the drug flow from the pump. For IsoMed pumps, refer to the appropriate pump technical manual for instructions on calculating the time required for drug to advance to the catheter tip. For programmable pumps, refer to the appropriate pump programming manual for instructions on priming the catheter.

4. Upon completion of the flush, close the clamp, and carefully remove the needle from the catheter access port.

5. Properly discard the needle.

6. Remove the cleansing agent from the patient's skin using an alcohol

pad.

7. Apply an adhesive bandage, if desired.

8. Discard all components of the kit.

Clearing a catheter occlusion

For Vascular Applications Only

1. Assemble a 10-mL syringe, extension set with a clamp, and the correct

catheter access port needle supplied in the catheter access port kit. Note: The template and needle are pump-specific. Match the name on the template with the name of the pump. Match the color and gauge of the needle to the color and gauge indicated on the template (purple for IsoMed and SynchroMed II pumps; orange for SynchroMed EL pumps). If you are unsure of which pump is implanted, consult the patient’s record.

2. Fill the syringe with 5 mL of a heparinized solution (if not contraindicated).

3. Enter the catheter access port as described in the steps on page 13.

4. Gently alternate irrigation and aspiration to open catheter.

5. If resistance continues, aspirate as much fluid as possible from the

catheter access port. Use a 1-mL tuberculin syringe, extension set with a clamp, and catheter access port needle and inject 0.5 mL of

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heparinized solution (1000 U/mL) to lightly pressurize the system. Close the clamp, and remove the needle.

Cautions:

Injection of more than 0.5 mL of fluid into the catheter access

▪

port under high pressure may cause catheter disconnection or catheter damage and subsequent fluid leakage.

Do not exceed an injection rate of 5 mL per minute when

▪

injecting into the catheter access port.

6. With the appropriate needle attached to the syringe, check for catheter patency in 10 minutes using a 10-mL syringe filled with 5 mL of heparinized solution (1000 U/mL). Lightly pressurize the syringe and wait 10 to 15 seconds to observe for loss of resistance. Do not force infusion.

7. If the catheter remains occluded, aspirate through the catheter access port to remove the original 0.5 mL of heparinized solution.

8. Repeat step 4 using 0.5 mL of heparinized solution, urokinase, or streptokinase (refer to drug labeling for complete instructions) and wait 10 to 30 minutes before checking for catheter patency. Attempt to dislodge the clot before flushing.

Technical support

A toll-free technical support service is available 24 hours a day for clinicians managing patients with Medtronic implantable infusion pumps. Telephone Customer Service at: 1-800-707-0933.

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Emergency procedures

Baclofen injection overdose

Consult the patient's medical record or with the patient's physician to confirm the drug or drug concentration within the pump reservoir.

Symptoms

Drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, hypothermia, seizures, rostral progression of hypotonia, and loss of consciousness progressing to coma.

There is no specific antidote for treating overdoses of intrathecal baclofen injection.

Actions

See table on the following page.

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Table 1. Intrathecal baclofen injection overdose emergency

Maintain airway/breathing/circulation.

Intubation and respiratory support may be necessary.

Empty pump reservoir to stop drug flow.

Record amount withdrawn.

procedures

FOR INTRATHECAL

OVERDOSE:

If not contraindicated, withdraw 30 – 40 mL CSF by lumbar puncture or through the catheter access port to reduce the concentration of baclofen in the CSF. Use only a 24-gauge or smaller, 1.5- or 2.0-inch (3.8- or

5.1-cm), needle for withdrawal from the catheter access port.

Notify patient's physician managing intrathecal baclofen injection

FOR SUBCUTANEOUS

OVERDOSE: (eg, pocket fill)

Proceed immediately to the next step.

therapy.

Continue to monitor closely for symptom recurrence.

Report incident to Medtronic, Inc.

Use a 25-gauge needle for withdrawal from a SynchroMed or SynchroMed EL catheter access port. Use a 24- or 25-gauge needle for withdrawal from a SynchroMed II or IsoMed catheter access port.

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Baclofen injection underdose/withdrawal

Consult the patient's medical record or with the patient's physician to confirm the drug or drug concentration within the pump reservoir.

Symptoms of underdose

Pruritus without rash, hypotension, paresthesia, fever, and altered mental state. Priapism may develop or recur if treatment with intrathecal baclofen is interrupted.

Symptoms of withdrawal

Exaggerated rebound spasticity and muscle rigidity, rhabdomyolysis, and multiple organ failure. The condition may resemble autonomic dysreflexia, sepsis, malignant hyperthermia, and neuroleptic-malignant syndrome.

Actions

See table on following page.

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Table 2. Intrathecal baclofen injection underdose/

withdrawal emergency procedures

Initiate life-sustaining measures if indicated.

If a patient receiving intrathecal baclofen injection presents with the signs and symptoms suggestive of withdrawal (see previous page), the following is consistent with that suggested by a panel of

therapy-experienced clinicians convened to explore this issue.

1. Immediately contact a physician experienced in intrathecal baclofen injection, preferably the physician managing the therapy for the patient in question; follow the recommendations of this physician. This step is important even if the patient’s signs and symptoms seem mild.

2. If a physician experienced in intrathecal baclofen injection is unavailable, consider instituting one or more of the following options, unless otherwise contraindicated:

high-dose oral* or enteral baclofen

▪

restoration of intrathecal baclofen injection infusion

▪

intravenous benzodiazepines by continuous or intermittent

▪

infusion, titrating the dosage until the desired therapeutic effect is achieved

* Note: Oral baclofen should not be relied upon as the sole treatment for intrathecal baclofen injection withdrawal syndrome.

Report incident to Medtronic, Inc.

Refer to the drug manufacturer’s package insert for a complete list of indications, contraindications, warnings, precautions, adverse events, and dosage and administration information.

Coffey RJ, Edgar TS, Francisco GE, et al. Abrupt withdrawal from the intrathecal baclofen: recognition and management of a potentially lifethreatening syndrome. Arch Phys Med Rehabil. 2002;83:735-741.

a,b

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Morphine intrathecal/epidural overdose

Consult the patient's medical record or with the patient's physician to confirm the drug or drug concentration within the pump reservoir.

Symptoms

Respiratory depression with or without concomitant central nervous system depression (ie, dizziness, sedation, euphoria, anxiety, seizures, respiratory arrest).

Actions

See figure on the following page.

Respiratory resuscitation and intubation may be necessary.

Maintain airway/breathing/circulation.

Give naloxone 0.4 – 2 mg intravenously.

a,b,c

FOR INTRATHECAL/EPIDURAL OVERDOSE: FOR SUBCUTANEOUS

OVERDOSE:

If not contraindicated, withdraw 30 – 40 mL of

CSF through the catheter access port or by lumbar

puncture to reduce CSF morphine concentration.

Use only a 24-gauge

(3.8 or 5.1 cm), needle for withdrawal from the

or smaller, 1.5 or 2.0 inch

catheter access port.

Empty pump reservoir to stop drug flow.

Record amount withdrawn.

(eg, pocket fill)

Proceed immediately

to the next step.

No ResponseResponse

Continue to monitor closely for symptom recurrence.

Since the duration of the effect of IV naloxone is shorter than the effect of intrathecal/epidural and

subcutaneous morphine, repeated administration

may be necessary.

Continue to perform

life-sustaining

measures.

No Recurrence Recurrence

Repeat naloxone every 2 – 3 minutes to maintain

adequate respiration.

If no response is observed after 10 mg of naloxone, the

diagnosis of narcotic-induced toxicity should be questioned.

see naloxone package insert.

a,b

For continuous IV infusion,

a,b

Notify patient’s physician managing intrathecal pain therapy.

Figure 3. Morphine intrathecal/epidural overdose emergency

procedures.

Preservative-free morphine sulfate sterile solution manufacturer's

package insert.

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Naloxone hydrochloride manufacturer's package insert.

Refer to the drug manufacturer's package insert for a complete list of indications, contraindications, warnings, precautions, adverse events, and dosage and administration information.

Use a 25-gauge needle for withdrawal from a SynchroMed or SynchroMed EL catheter access port. Use a 24- or 25-gauge needle for withdrawal from a SynchroMed II or IsoMed catheter access port.

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Emergency procedure to empty pump reservoir

Equipment

22-gauge noncoring needle

▪

20-mL syringe

▪

3-way stopcock or extension set with clamp

▪

Antiseptic agent

▪

Cautions:

Do not use an open syringe when emptying the IsoMed Pump. The

▪

pump reservoir contents are under significant pressure and can eject through an open syringe when emptying the pump. Ejection of pump contents under pressure can result in procedural delays and a potential risk to the clinician or patient.

Do not spill or leak vesicant or cytotoxic drug into adjacent tissue

▪

during pump procedures. Spillage or leakage of vesicant drug into adjacent tissue can result in significant local tissue damage.

1. Assemble the needle, syringe, and stopcock or extension set.

2. Locate the pump by palpation. The reservoir fill port is located in the

CENTER of the pump. If you have difficulty identifying the pump features, you may seek

assistance from another clinician. If deemed necessary by the clinician, x-ray and fluoroscopy can be used to assist in locating or determining the orientation of the pump.

3. Prepare the injection site by cleansing the area using an antiseptic agent.

4. Gently insert the 22-gauge noncoring needle into the center of the reservoir fill port until the needle touches the bottom of the reservoir fill port (Figure 4).

During proper needle insertion, you will feel the needle:

pass through the patient's skin and subcutaneous tissue,

▪

hit the silicone septum,

▪

(Scar tissue, if present, can feel similar to the septum.) pass through the septum, and

▪

hit the metal bottom of the reservoir fill port.

▪

(The top of the pump is metal and hitting the top of the pump can feel similar to hitting the bottom of the reservoir fill port.)

If excessive resistance is encountered during needle insertion, reassess placement. Do not force the needle. The feel of abnormal resistance during the procedure may be an indication that the needle is not in the center of the reservoir fill port.

Septum

Needle

Bottom of the reservoir fill port

Figure 4. View inside of a SynchroMed programmable pump while the

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needle is fully and properly inserted.

Subcutaneous tissue

5. For SynchroMed programmable pumps: Open the clamp or stopcock and slowly withdraw the fluid from the reservoir into the empty syringe.

For IsoMed nonprogrammable pumps: Maintain light pressure on the syringe plunger when emptying the pump. Open the clamp or stopcock and slowly withdraw the fluid from the reservoir into the empty syringe. If backflow is not observed, remove the needle from the reservoir fill port and repeat steps 2 – 5. If backflow still does not occur, and the Expected Volume is greater than 2 mL, contact your Medtronic representative.

6. Depending on pump reservoir volume, more than one syringe may be needed to empty the pump. Close the clamp or stopcock when changing syringes.

7. Completely empty the pump. For SynchroMed programmable pumps: When the pump is empty,

the bubbles will stop forming, and negative pressure in the syringe can be felt.

For IsoMed nonprogrammable pumps: Wait approximately 5 seconds after fluid stops flowing into the syringe to ensure that all fluid is removed and the pump is empty.

8. Remove the needle from the reservoir fill port.

9. Record in patient chart the amount of fluid emptied from the pump

reservoir.

Special notice

The Medtronic Model 8540 and Model 8543 Catheter Access Port Kits are designed to be used for accessing the catheter access port of the Medtronic implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps. Medtronic cannot warrant or guarantee the catheter access port kit because, despite the exercise of all due care in design, component selection, manufacture, and testing prior to sale, the components of the catheter access port kit may be easily damaged before or during use by improper handling or other intervening acts.

2016-12-01 English 23

Medtronic® Neuromodulation MODEL 8540 AND MODEL 8543 CATHETER ACCESS PORT KITS

LIMITED WARRANTY

A. This Limited Warranty provides the following assurance to the purchaser

of the Medtronic Model 8540 or 8543 packaged herein, hereafter referred to as the “Product”:

(1) Should the Product fail to function within normal tolerances due to a

defect in materials or workmanship prior to its "Use By" date, Medtronic will at its option: (a) issue a credit to the purchaser equal to the Purchase Price, as defined in Subsection A(2), against the purchase of the replacement Product or provide a functionally comparable replacement Product at no charge.

(2) As used herein, Purchase Price shall mean the lesser of the net

invoiced price of the original, or current functionally comparable, or replacement Product.

B. To qualify for this Limited Warranty set forth in Section A(1), the following

conditions must be met: (1) The Product must be used prior to its "Use By" date. (2) The unused portion of the Product must be returned to Medtronic

within thirty (30) days after discovery of the defect and shall be the Property of Medtronic.

(3) The Product must not have been altered or subjected to misuse,

abuse, or accident.

(4) The Product must be used in accordance with the labeling and

instructions for use provided with the Product.

C. This Limited Warranty is limited to its express terms. In particular:

(1) Except as expressly provided by this Limited Warranty, MEDTRONIC

IS NOT RESPONSIBLE FOR ANY DIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT, MALFUNCTION OR FAILURE OF THE PRODUCT, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT OR OTHERWISE.

(2) This Limited Warranty is made only to the purchaser who uses the

Product. AS TO ALL OTHERS, MEDTRONIC MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WHETHER ARISING FROM STATUTE, COMMON LAW, CUSTOM OR OTHERWISE. NO EXPRESS OR IMPLIED WARRANTY TO THE PATIENT SHALL EXTEND BEYOND THE PERIOD SPECIFIED IN A(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE REMEDY AVAILABLE TO ANY PERSON.

(3) The exclusions and limitations set out above are not intended to, and

should not be construed so as to contravene mandatory provisions of applicable law. If any part or term of this Limited Warranty is held to be illegal, unenforceable or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of the Limited Warranty shall not be affected, and all rights and obligations shall be construed and enforced as if this Limited Warranty did not contain the particular part or term held to be invalid. This Limited Warranty gives the purchaser specific legal rights. The purchaser may also have other rights that vary from country to country or from state to state.

(U.S. Customers Only)

This Limited Warranty is provided by Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604. It applies only in the United States. Areas outside the United States should contact their local Medtronic representative for exact terms of the Limited Warranty.

24 English 2016-12-01

(4) No purchaser has any authority to bind Medtronic to any

representation, condition or warranty except this Warranty.

2016-12-01 English 25

26 English 2016-12-01

Contacts:

Asia:

Medtronic International Ltd. Tel. 02919-1300 Fax 02891-6830

Medtronic Asia Ltd. Tel. (02)-548-1148

Fax (02)-518-4786

Australia:

Medtronic Australasia Pty. Ltd. 97 Waterloo Road North Ryde, NSW 2113 Australia Tel. +61-2-9857-9000 Fax +61-2-9878-5100 Toll-free 1-800-668-670

Austria:

Medtronic Österreich GmbH Tel. 01-240440 Fax 01-24044-100

Belgium:

Medtronic Belgium S.A. Tel. 02-456-0900 Fax 02-460-2667

Canada:

Medtronic of Canada Ltd. Tel. (1-905)-460-3800 Fax (1905)-826-6620

Czech Republic:

Medtronic Czechia s.r.o. Tel. 2-965-795-80 Fax 2-965-795-89

Denmark:

Medtronic Danmark A/S Tel. 45-32-48-18-00 Fax 45-32-48-18-01

Finland:

Medtronic Finland Oy/LTD Tel. (09)-755-2500 Fax (09)-755-25018

France:

Medtronic France S.A.S. Tel. 01-5538-1700 Fax 01-5538-1800

Germany:

Medtronic GmbH Tel. (02159)-81490 Fax (02159)-8149100

Greece:

Medtronic Hellas S.A. Tel. 210-67-79-099 Fax 210-67-79-399

Hungary:

Medtronic Hungária Kft. Tel. 1-889-06-00 Fax 1-889-06-99

Ireland:

Medtronic Ireland Ltd. Tel. (01)-890-6522 Fax (01)-890-7220

Italy:

Medtronic Italia SpA Tel. 02-241371 Fax 02-241381

Tel. 06-328141 Fax 06-3215812

Japan:

Medtronic Japan Tel. 03-6776-0017 Fax 03-6774-4645

Latin America:

Medtronic, Inc. Tel. (1305)-500-9328 Fax (1786)-709-4244

Norway:

Medtronic Norge AS Tel. 67-10-32-00 Fax 67-10-32-10

Poland:

Medtronic Poland Sp. z.o.o. Tel. (022)-465-69-00 Fax (022)-465-69-17

Portugal:

Medtronic Portugal, Lda. Tel. 21-724-5100 Fax 21-724-5199

Russia:

Medtronic Russia Tel. (8495) 580-7377 Fax (8495) 580-7378

Slovakia:

Medtronic Slovakia, o.z. Tel. 0268 206 911 Fax 0268 206 999

Spain:

Medtronic Ibérica, S.A. Tel. 91-625-0400 Fax 91-650-7410

Sweden:

Medtronic AB Tel. 08-568-585-00 Fax 08-568-585-01

Switzerland:

Medtronic (Schweiz) AG Tel. 031-868-0100 Fax 031-868-0199

The Netherlands:

Medtronic B.V. Tel. (045)-566-8000 Fax (045)-566-8668

Turkey:

Medtronic Turkey Tel. +90 216 636 1000 Fax +90 216 636 1008

U.K.:

Medtronic U.K. Ltd. Tel. 01923-212213 Fax 01923-241004

USA:

Medtronic, Inc. Tel. (1-763)-505-5000 Fax (1-763)-505-1000 Toll-free: (1-800)-328-0810

Manufacturer

Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA www.medtronic.com Tel. +1-763-505-5000 Fax +1-763-505-1000

REP

Authorized Representative in the European Community

Medtronic B.V. Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands Tel. +31-45-566-8000 Fax +31-45-566-8668

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 Fax +41-21-802-7900

Asia-Pacific

Medtronic International Ltd. Suite 1106-11, 11/F, Tower 1, The Gateway, 25 Canton Road, Tsimshatsui, Kowloon, Hong Kong Tel. +852-2919-1300 Fax +852-2891-6830

Contacts for specific countries are listed inside this cover.

*M221380A009*

M221380A009

Medtronic 8540 Instructions for Use

Specifications and Main Features

Frequently Asked Questions

User Manual

Table of contents

Introduction

Package contents

Indications

Contraindications

Warnings

Precautions

Adverse events

Instructions for Use

Preliminary procedures

Preparing the access site

Intraspinal applications only

Vascular applications only

Flushing the catheter access port

Clearing a catheter occlusion

Technical support

Emergency procedures

Baclofen injection overdose

Symptoms

Actions

Baclofen injection underdose/withdrawal

Symptoms of underdose

Symptoms of withdrawal

Actions

Morphine intrathecal/epidural overdose

Symptoms

Actions

Emergency procedure to empty pump reservoir

Equipment

Special notice