Medtronic 8555 Instructions for Use

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Refill Kit 8555 for use with Medtronic Implantable Infusion Pumps

Instructions for Use

Rx only

2000

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

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

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 10

Adverse events 11

Instructions for use 12

For SynchroMed pump 12

Sterilization 12 Preliminary procedures 12 Emptying the SynchroMed pump 13 Refilling the SynchroMed pump 16 Programming the SynchroMed pump 19 After the refill procedure 19

For IsoMed pump 19

Sterilization 19 Preliminary procedures 19 Emptying the IsoMed pump 20 Refilling the IsoMed pump 23

Reservoir rinse procedure 26

Performing a reservoir rinse 26

Calculations for IsoMed pumps (fixed rate) only 26

Scheduling a refill 26 Calculating the time required for the drug to advance to the catheter tip 27 Calculating flow rate 28 Calculating infusion solution 28 Calculating IsoMed pump flow rate accuracy 29

Technical support 30

Emergency procedures 31

Baclofen injection overdose 31 Baclofen injection underdose/withdrawal 33 Morphine intrathecal/epidural overdose 35 Emergency procedure to empty pump reservoir 37

Special notice 38

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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Limited Warranty 39

Medtronic® Neuromodulation MODEL 8555 REFILL KIT LIMITED WARRANTY (U.S. Customers Only) 39

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Introduction

These instructions include only the procedure for refilling the pump reservoir. Refer to the appropriate pump technical manual for implanting instructions.

Package contents

The Model 8555 Refill Kit contains eight (8) sterile packs and each pack contains the following sterile components that are not made with natural rubber latex:

0.22-micron filter

▪

22-gauge noncoring needles (2)

▪

Template

▪

Extension set with a y-connector and a clamp

▪

Indications

The Model 8555 Refill Kit is intended for use in refilling Medtronic implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps.

Contraindications

Medtronic refill kits are contraindicated for all catheter access port procedures.

Warnings

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.

Changing drug or decreasing drug concentrations - Rinse the reservoir twice between solutions when changing drug or decreasing drug concentrations in the pump reservoir. A significant amount of drug may be present in the pump reservoir after emptying the pump. This residual volume cannot be removed by emptying the pump. Rinsing the reservoir between solutions minimizes the amount of drug in this residual volume but does not eliminate it. Failure to account for residual drug in the pump reservoir can result in a concentration that is different than intended and a clinically significant or fatal drug underdose or overdose. For programmable infusion pumps, program a Bridge Bolus after rinsing the reservoir twice.The Bridge Bolus advances the remaining old drug (the drug left in the pump tubing, catheter access port, and catheter after emptying and refilling the pump) to the catheter tip at the prior flow rate.

Refer to "Performing a reservoir rinse" on page 26 of this manual. Refer to the Programming Guide for bridge bolus procedures.

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 (pumps with a catheter access port) - Do not inject any contrast medium into the pump reservoir. Injecting contrast medium into the pump reservoir can impair pump operation.

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

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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.

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.

Infusion solution calculations - Correct calculation of the infusion solution is of critical importance in preventing overinfusion or underinfusion.

Refer to "Calculating infusion solution" on page 28 for instructions. Injection error during a pump refill procedure - Be certain you are

accessing the correct port when injecting fluids into the reservoir fill port of an implanted pump. ALWAYS:

identify the pump model and reservoir volume.

▪

identify the location of the reservoir fill 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. 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 pump refill procedure for any signs or symptoms that could indicate a pocket fill or any other drug-related adverse event due to the refill procedure. Seek emergency assistance as necessary. Refer to the refill kit manual or the Indications, Drug Stability and Emergency Procedures for SynchroMed and IsoMed

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Implantable Infusion Systems Reference Manual for emergency procedures associated with drug underdose and overdose.

Inadvertent injection into the catheter access port may result in a clinically significant or fatal drug overdose. Observe the patient after the pump refill procedure for any signs or symptoms that could indicate a drug-related adverse event due to the pump refill procedure.

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.

Mixing drugs - The effects that drug mixtures have on pump operation are unknown. Drugs can precipitate when mixed. These precipitates can inhibit pump flow or block the catheter, resulting in loss of therapy or a clinically significant or fatal drug underdose.

Overinfusion - Overinfusion is defined as the delivery of more drug volume than the programmed rate, exceeding the pump’s flow rate accuracy specification. Pump reservoir contents aspirated during a refill procedure that are less than expected may indicate that the pump has overinfused. Overinfusion may or may not be associated with clinically relevant symptoms. When the pump delivers more drug volume than the programmed rate, patients may experience overdose symptoms, and the pump reservoir will deplete more quickly than expected. Patients may experience underdose or withdrawal symptoms if the drug is depleted prior to the scheduled refill date from an overinfusing pump. At each refill visit, question and examine the patient for signs and symptoms of overdose, underdose, and withdrawal.

The low reservoir alarm of an overinfusing pump will not sound if the pump reservoir is prematurely depleted. The low reservoir alarm is

calculated from the pump’s programmed delivery rate and is not a direct measurement of the actual drug volume in the pump reservoir. Multiple factors may increase the likelihood of overinfusion, including: nonindicated drug formulations, overfilling of the pump reservoir, operation of the pump with no fluid in the reservoir, catheter occlusion, and pump stops or motor stalls lasting more than 48 hours.

Refer to the appropriate drug labeling for specific drug underdose or overdose symptoms and methods of management. If overinfusion is strongly suspected, contact Medtronic. Reducing the dose and/or concentration is not recommended as a solution for overinfusion. If immediate discontinuation of therapy is clinically appropriate for the patient, program the pump to minimum rate mode, and aspirate any remaining drug from the reservoir. Five occurrences of overinfusion have been identified in Medtronic’s prospective, long-term multi-center registry study (Product Surveillance Registry) as of January 2016, resulting in a rate estimate of less than 0.14% (approximately 1 in 700).

Overpressurization (IsoMed Pumps) - Do not overfill the pump reservoir. Overfilling the pump reservoir can result in overpressurization and overinfusion. Overinfusion can lead to a clinically significant or fatal drug overdose. Overpressurization can damage the pump. To prevent overfilling:

Always identify the pump model and reservoir volume before filling or

▪

refilling; Always empty the pump reservoir completely before filling or refilling;

▪

and Do not exceed the maximum reservoir volume indicated in the pump

▪

labeling.

Patient travel - Patients should notify their clinicians of any travel plans. Clinicians need this information to coordinate patient care and pump refills and help prevent 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.

Pocket fill - If it is suspected or known that all or part of the drug was injected into the pocket during the refill procedure, monitor the patient closely for signs and symptoms of overdose in an appropriate facility for a sufficient amount of

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time or until the symptoms have resolved. Refer to “Emergency Procedures” in the Indications, Drug Stability, and Emergency Procedures manual, the refill instructions for use, and the appropriate drug labeling for specific drug underdose and overdose symptoms and methods of management.

Pump reservoir pressure (IsoMed Pumps) - Do not use an open syringe when emptying the 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.

Refill - Patients must return to the clinic for refills at the prescribed times. Failure to return to the clinic for refills at the prescribed times can result in the actual flow rate of the pump being less than expected, 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. Failure to return at the prescribed times can also damage the pump, requiring surgical replacement.

Refill kit components - The appropriate Medtronic refill kit MUST be used during all refill procedures for Medtronic implantable infusion pumps. Using components other than Medtronic components or a kit other than the appropriate refill 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 or overdose.

Reservoir fill port injections - Do not use excessive force when accessing the reservoir fill port. Excessive force can result in damage to the needle or pump requiring surgical revision or replacement, and 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 or overdose.

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.

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.

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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.

Reservoir valve activation (programmable pumps) - Do not prematurely activate the pump reservoir valve. Activation of the pump reservoir valve seals the pump reservoir valve closed. Unusual resistance or the inability to inject the entire fill volume may indicate activation of the pump reservoir valve. If the valve closes, a portion of the reservoir contents must be delivered or removed before filling can be completed, and procedural delays can occur. To prevent activation of the pump reservoir valve during emptying and filling procedures:

completely aspirate all contents of the pump reservoir before filling;

▪

do not allow air into the pump reservoir through an open needle in the

▪

septum or an unclamped extension; and do not exceed the maximum reservoir volume indicated in the pump

▪

labeling.

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.

Therapy discontinuance - If therapy is discontinued for an extended period, fill the pump reservoir with preservative-free saline in intraspinal applications or with the appropriate heparinized solution (if not contraindicated) in vascular applications. For programmable pumps, program the pump to infuse at the minimum flow rate. Refill the pump as needed to ensure the pump always contains fluid in the reservoir and fluid pathway. Stopping the pump for extended periods or allowing the pump reservoir to empty completely can damage the system and require surgical replacement.

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 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

▪

Reservoir contamination

▪

Overpressurization of the reservoir

▪

Injection into pocket or subcutaneous tissue

▪

Activation of reservoir valve

▪

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Instructions for use

Become thoroughly familiar with all product literature before using this refill kit. Refer to the appropriate section based on the pump.

SynchroMed pump - go to page 12.

▪

IsoMed pump - go to page 19.

▪

For SynchroMed pump

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:

From the refill kit:

Extension set with a y-connector and a clamp

▪

0.22-micron filter

▪

22-gauge noncoring needle

▪

Template

▪

Locally supplied:

10-mL filling syringe, optional

▪

20-mL empty syringe(s)

▪

Fenestrated drape

▪

Syringe containing prescribed fluid

▪

Cleansing agent

▪

Sterile gloves

▪

Alcohol pads or swabs

▪

Adhesive bandage, optional

▪

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

3. Prepare the programmer for use. Refer to the appropriate programming guide for instructions.

4. Confirm the:

pump model

▪

reservoir volume (ie, expected volume)

▪

location of the pump

▪

Note: The model and reservoir volume can be confirmed by the programmer. Alternatively, a radiopaque identifier in the pump shows the pump model and identifies Medtronic as the pump manufacturer on

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a standard x-ray (Figure 1). A three-letter code designates the pump model.

Radiopaque identifier

Medtronic symbol

Model designator

Figure 1. A radiopaque identifier on a SynchroMed II pump.

Confirm that the volume of the prescribed fluid does not exceed the reservoir volume of the pump.

Emptying the SynchroMed pump

1. Prepare the injection site by cleansing the area.

2. Open the kit. Put on sterile gloves.

3. Place the drape, exposing the pump site.

4. Using sterile procedures, assemble the needle, extension set, and

empty syringe as follows: a. Connect the empty syringe to the extension set (Figure 4). b. Connect the needle to the extension set.

5. Palpate the pump and identify the location of the catheter access port

and the edges of pump. Factors that may make it difficult to locate the pump include, but are not limited to:

deep implant

▪

patient position (eg, a seated patient)

▪

scar tissue at the pump implant site

▪

seroma

▪

the pump is tilted in the pocket

▪

obesity

▪

pump movement within the pocket

▪

weight gain after implant

▪

weight loss after implant

▪

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.

6. Place the template on the skin over the pump, and align the refill

template correctly based on the model of the pump that is being refilled (Figure 2). Align the edges of the template with the edges of the pump.

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Use the center circle of the template to insert the needle into the reservoir fill port.

Align the left edge

of the

template

with the

left edge

SynchroMed EL

of the

pump

Aligning the refill template with the SynchroMed EL pump

Figure 2. Aligning the refill template according to the pump model.

Close the clamp.

8. Gently insert the 22-gauge needle perpendicular to the surface of the

pump through the reservoir fill port until the needle touches the bottom of the reservoir fill port (Figures: 3 – 4).

Note: The pump may be tilted within the pocket and therefore the

needle angle may not be perpendicular to the patient's body. 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.

center of the template and into the center of the

Aligning the refill template with the SynchroMed II pump

Align the right edge of the template with the right edge of the SynchroMed II pump

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Septum

Needle

Bottom of the reservoir fill port

Figure 3. View inside of a SynchroMed programmable pump while the

Figure 4. Close the clamp and insert the needle into the reservoir fill port.

Note:

location, reassess its position. Factors that may contribute to difficulty inserting the needle into the reservoir fill port include, but are not limited to:

the pump is flipped in the pocket

▪

deep implant

▪

patient position (eg, a seated patient)

▪

patient movement (eg, spasticity, difficulty hold still)

▪

localized muscle spasms at the pump implant site

▪

scar tissue at the pump implant site

▪

seroma

▪

the pump is tilted in the pocket

▪

obesity

▪

pump movement within the pocket

▪

weight gain after implant

▪

weight loss after implant

▪

9. Open the clamp and slowly withdraw the fluid from the reservoir into the

empty syringe.

needle is fully and properly inserted.

Needle

At any point during the procedure, if in doubt about the needle

Subcutaneous tissue

Empty syringe

Y-connector

Closed clamp

Extension set

Te mp l at e

Reservoir fill port

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Note: If the withdrawn fluid has an unexpected appearance (eg,

evidence of blood), this may indicate that the needle is not properly inserted into the pump.

10. If the syringe maximum capacity is reached before the reservoir is

completely empty, more than one syringe will be needed to empty the pump.

a. Close the clamp. b. Remove the full syringe. c. Attach an empty syringe. d. Verify that the needle is in the pump reservoir fill port. e. Repeat step 9, then continue to step 11.

11. Completely empty the pump. When the pump is empty, the bubbles will

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

12. Close the clamp and remove the syringe from the extension set. Note: Keep the needle in the reservoir fill port and the clamp closed for

the pump refill procedure that follows.

13. Note the amount withdrawn from the pump for entry in the patient's

record.

14. Compare the amount withdrawn from the pump to the expected volume.

See the pump programmer for the expected volume. The amount withdrawn should approximately equal the expected volume. If a less than expected volume is observed, potential causes of the volume discrepancy could include: inaccurate volume measurements, incomplete pump aspiration, incorrect volume entry into clinician programmer at refills, unrecognized partial pocket fill, aspiration of pump medication by patient or caregiver, or overinfusion.

Note: Immediately following the refill procedure:

record the amount withdrawn and the expected volume in the

▪

patient's record. record any volume discrepancy and compare volume discrepancies

▪

from visit to visit.

15. Discard the fluid and syringe as appropriate for the fluid content in

accordance with institutional policies and applicable regulations.

Refilling the SynchroMed pump

Warning: Overinfusion is defined as the delivery of more drug volume

than the programmed rate, exceeding the pump’s flow rate accuracy specification. Pump reservoir contents aspirated during a refill procedure that are less than expected may indicate that the pump has overinfused. Overinfusion may or may not be associated with clinically relevant symptoms. When the pump delivers more drug volume than the programmed rate, patients may experience overdose symptoms, and the pump reservoir will deplete more quickly than expected. Patients may experience underdose or withdrawal symptoms if the drug is depleted prior to the scheduled refill date from an overinfusing pump. At each refill visit, question and examine the patient for signs and symptoms of overdose, underdose, and withdrawal.

The low reservoir alarm of an overinfusing pump will not sound if the pump reservoir is prematurely depleted.

is calculated from the pump’s programmed delivery rate and is not a direct measurement of the actual drug volume in the pump reservoir. Multiple factors may increase the likelihood of overinfusion, including: nonindicated drug formulations, overfilling of the pump reservoir, operation of the pump with no fluid in the reservoir, catheter occlusion, and pump stops or motor stalls lasting more than 48 hours.

The low reservoir alarm

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remaining drug from the reservoir. Five occurrences of overinfusion have been identified in Medtronic’s prospective, long-term multi-center registry study (Product Surveillance Registry) as of January 2016, resulting in a rate estimate of less than 0.14% (approximately 1 in 700).

Warning: Pocket fill

includes the pump pocket. 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 pump refill procedure for any signs or symptoms that could indicate a pocket fill or any other drugrelated adverse event due to the refill procedure.

Inadvertent injection into the catheter access port may result in a

clinically significant or fatal drug overdose. Observe the patient after the pump refill procedure for any signs or symptoms that could indicate a drug-related adverse event due to the pump refill procedure.

Warning: If it is suspected or known that all or part of the drug was

injected into the pocket during the refill procedure, monitor the patient closely for signs and symptoms of overdose in an appropriate facility for a sufficient amount of time or until the symptoms have resolved. Refer to “Emergency Procedures” in the Indications, Drug Stability, and Emergency Procedures manual, the refill instructions for use, and the appropriate drug labeling for specific drug underdose and overdose symptoms and methods of management.

Warning: Swelling at the injection site may indicate that the needle tip

is not properly located within the pump reservoir, and the result could be pocket fill. 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. Absence of swelling does not in all cases demonstrate that the needle tip is properly located. If swelling is present, stop injecting and observe the patient for any signs or symptoms that could indicate a pocket fill or any other drug-related adverse event.

1. If changing drug or drug concentrations, refer to "Performing a reservoir

rinse" on page 26. Otherwise, proceed to the next step.

2. Confirm that the refill volume of the prescribed fluid does not exceed the

reservoir volume of the pump.

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

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

5. Purge all air from the filter.

6. Attach the syringe with the prescribed fluid and filter to the extension set

(Figure 5).

Note: An optional 10-mL filling syringe may be used to lower the force

required to depress the syringe while filling the pump (refer to the procedure in "Refilling the IsoMed pump" on page 23).

7. Before and during injection, verify that the needle remains fully inserted

to the bottom of the reservoir fill port. Do not apply tension to the extension tubing because the needle may be pulled out from the reservoir.

8. Open the clamp and as the clamp is opened, observe the following

indications that the needle continues to be properly positioned:

▪

9. Slowly depress the plunger on the syringe to inject the prescribed fluid

into the pump reservoir. While injecting the prescribed fluid, verify that the needle remains properly located within the reservoir (Figure 5).

is the improper injection into the subcutaneous tissue, which

The bubbles in the extension set are immediately drawn into the pump.

The plunger may move slightly when the drug is initially drawn into the pump.

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a. Periodically withdraw and observe a portion of the drug to confirm

that the drug has the expected appearance.

b. After confirming that the needle remains in the reservoir, resume

injecting fluid.

Syringe with prescribed fluid

Figure 5. Open the clamp and inject into the pump reservoir.

Caution: If you encounter unusual resistance before the maximum

reservoir volume is injected or you are unable to inject fluid, the reservoir valve may have been activated. Activation of the pump reservoir valve seals the pump reservoir valve closed. If the valve closes, a portion of the reservoir contents must be delivered or removed before filling can be completed, and procedural delays can occur.

To prevent activation of the pump reservoir valve during emptying and filling procedures:

completely aspirate all contents of the pump reservoir before

▪

filling; do not allow air into the pump reservoir through an open needle

▪

in the septum or an unclamped extension; and do not exceed the maximum reservoir volume indicated in the

▪

pump labeling.

10. If you have activated the reservoir valve, complete steps a – g below.

Otherwise, proceed to step 11. a. Discontinue injection.

b. Close the clamp. c. Remove the syringe with prescribed fluid and attached filter. d. Attach an empty 20-mL syringe to the extension set. e. Open the clamp, and aspirate until all fluid/air is removed. f. Close the clamp and remove the syringe containing the aspirate

from the extension set and discard the syringe.

g. Repeat steps 2 – 10.

Note: For pumps with a reservoir valve, the amount of time before the

valve will release is dependent on the duration and the amount of pressure applied after the valve is first activated. The more pressure exerted, the longer it may take to release the valve.

11. When filling is complete, close the clamp and carefully remove the

needle from the reservoir fill port.

Filter

Open clamp

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Note: If you are unsure whether drug was injected correctly into the

pump, completely aspirate the pump to verify that all of the injected drug can be removed.

12. Remove the cleansing agent from the patient’s skin using an alcohol

pad.

13. Apply an adhesive bandage, if desired.

14. Discard all components of the kit.

Programming the SynchroMed pump

1. If the drug concentration or drug has been changed, program a bridge

bolus. Refer to the programming guide for the pump software.

2. If any prescription information has changed, enter the changed

information into the clinician programmer: for example drug name, drug concentration, infusion information, or volume of prescribed fluid in the pump reservoir.

3. Update the pump.

After the refill procedure

1. Record the amount withdrawn and the expected volume in the patient's

record.

2. Record any volume discrepancy and compare volume discrepancies

from visit to visit.

3. Print out the desired refill-related reports, and place the final pump

settings in the patient file.

4. Determine the refill date from the printout, and schedule a refill

appointment.

For IsoMed pump

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:

From the refill kit:

Extension set with a y-connector and a clamp

▪

0.22-micron filter

▪

22-gauge noncoring needle

▪

Template

▪

Locally supplied:

10-mL filling syringe

▪

20-mL empty syringe(s)

▪

Fenestrated drape

▪

Syringe containing prescribed fluid

▪

Cleansing agent

▪

Sterile gloves

▪

Alcohol pads or swabs

▪

Adhesive bandage, optional

▪

2. Refer to the appropriate drug labeling for indications, contraindications,

warnings, precautions, dosage and administration information, and screening procedures.

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3. Confirm the:

pump model

▪

reservoir volume

▪

location of the pump

▪

flow rate

▪

Note: The pump model, reservoir volume, and flow rate can be

determined from an x-ray of the pump (Figure 6).

Medtronic logo

Reservoir volume (20mL)

X-ray identification tag

Medtronic engineering revision level (1)

Figure 6. Locate the x-ray identification tag for an IsoMed pump.

Confirm that the volume of the prescribed fluid does not exceed the reservoir volume of the pump.

Flow rate (1.5 mL/day)

Model (8472)

Emptying the IsoMed pump

1. Prepare the injection site by cleansing the area.

2. Open the kit. Put on sterile gloves.

3. Place the drape, exposing the pump site.

4. Using sterile procedures, assemble the needle, extension set, and

empty syringe as follows: a. Connect the empty syringe to the extension set (Figure 8). A syringe

or lidded syringe may be used.

b. Connect the needle to the extension set.

5. Palpate the pump and identify the location of the catheter access port

and the edges of pump. Factors that may make it difficult to locate the pump include, but are not limited to:

deep implant

▪

patient position (eg, a seated patient)

▪

scar tissue at the pump implant site

▪

seroma

▪

the pump is tilted in the pocket

▪

obesity

▪

pump movement within the pocket

▪

weight gain after implant

▪

weight loss after implant

▪

6. Place the template on the skin over the pump, and align the refill

template (Figure 7) correctly. Align the rounded edges of the template with the edges of the pump. Use the center circle of the template to insert the needle into the reservoir fill port.

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Figure 7. A pump template, which shows the center circle. The center circle

7. Close the clamp.

8. Gently insert the 22-gauge needle perpendicular to the surface of the

pump through the reservoir fill port until the needle touches the bottom of the reservoir fill port (Figure 8).

Note: The pump may be tilted within the pocket and therefore the

needle angle may not be perpendicular to the patient's body. During proper needle insertion, you will feel the needle:

▪ ▪

is used to help locate the reservoir fill port.

Warning: With IsoMed pumps, inserting the needle at the edge of

the reservoir fill port may result in a pocket fill. 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. Excessive resistance may indicate that the needle is improperly positioned. Do not force the needle excessively. Forcing the needle excessively may cause damage to the pump and needle, and cause injury to the patient.

center of the template and into the center of the

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.)

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Empty syringe

Y-connector

Closed clamp

Needle

Figure 8. Close the clamp and insert the needle into the reservoir fill port.

Note:

At any point during the procedure, if in doubt about the needle location, reassess its position. Factors that may contribute to difficulty inserting the needle into the reservoir fill port include, but are not limited to:

the pump is flipped in the pocket

▪

deep implant

▪

patient position (eg, a seated patient)

▪

patient movement (eg, spasticity, difficulty hold still)

▪

localized muscle spasms at the pump implant site

▪

scar tissue at the pump implant site

▪

seroma

▪

the pump is tilted in the pocket

▪

obesity

▪

pump movement within the pocket

▪

weight gain after implant

▪

weight loss after implant

▪

9. When using a syringe with a plunger, maintain light pressure on the

syringe plunger when emptying the pump. Open the clamp 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 6 – 9. If backflow still does not occur, and the Expected Volume is greater than 2 mL, contact your Medtronic representative.

10. If the syringe maximum capacity is reached before the reservoir is

completely empty, more than one syringe will be needed to empty the pump.

a. Close the clamp. b. Remove the full syringe. c. Attach an empty syringe. d. Verify that the needle is in the pump reservoir fill port. e. Repeat step 9, then continue to step 11.

11. Completely empty the pump. Wait approximately 5 seconds after fluid

stops flowing into the syringe to ensure that all fluid is removed and the pump is empty.

12. Close the clamp and remove the syringe from the extension set. Note: Keep the needle in the reservoir fill port and the clamp closed for

the pump refill procedure that follows.

13. Note the amount withdrawn from the pump for entry in the patient's

record.

Extension set

Te mp l at e

Reservoir fill port

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14. Compare the amount withdrawn from the pump to the expected volume.

To determine the expected volume, refer to the flow rate accuracy calculation (see "Calculating IsoMed pump flow rate accuracy" on page 29). The amount withdrawn should approximately equal the expected volume.

Note: A flow rate accuracy of ±25% or less is within the expected flow

rate accuracy. If a significant discrepancy is found, contact a local Medtronic representative.

15. Discard the fluid and syringe as appropriate for the fluid content in

accordance with institutional policies and applicable regulations.

Refilling the IsoMed pump

Warning: Pocket fill

Inadvertent injection into the catheter access port may result in a

Warning: If it is suspected or known that all or part of the drug was

Warning: Swelling at the injection site may indicate that the needle tip

Note: IsoMed pump reservoir contents are under significant pressure and

require the use of a 10-mL filling syringe to inject drug into the reservoir. The filling syringe is attached to the angled, non-valved end of the y-connector. The straight end with the blue cap has a one-way valve to prevent reservoir

is the improper injection into the subcutaneous tissue, which

2017-06-01 English 23

backflow from flowing into the syringe with the prescribed fluid. The straight end is intended only for the filtered syringe containing fresh drug (Figure 9).

Angled end

Straight end with blue cap

Extension set

Needle connection

Clamp

Figure 9. Extension set.

If changing drug or drug concentrations, refer to "Performing a reservoir

rinse" on page 26. Otherwise, proceed to the next step.

2. Confirm that the refill volume of the prescribed fluid does not exceed the

reservoir volume of the pump.

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

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

5. Purge all air from the filter.

6. Attach the 10-mL filling syringe and the syringe with the prescribed fluid

and the filter to the extension set as follows (Figure 10): a. Connect the syringe with prescribed fluid and filter to the straight,

valved end of the y-connector (after removing the cap).

b. Connect the 10-mL filling syringe to the angled, non-valved end of

the y-connector.

7. Before and during injection, verify that the needle remains fully inserted

to the bottom of the reservoir fill port. Do not apply tension to the extension tubing because the needle may be pulled out from the reservoir.

8. With the clamp closed, slowly depress the plunger on the syringe with

the prescribed fluid to inject the prescribed fluid into the 10-mL filling syringe. Refer to Figure 10 (arrows indicate direction of fluid flow). Maintain light pressure on the filling syringe plunger during the filling process.

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Syringe with prescribed fluid

Filling syringe

Filter

Y-connector

Closed clamp

Te mp l at e

Reservoir fill port

Figure 10. Fill 10-mL filling syringe with prescribed fluid (arrows indicate

Open the clamp and slowly depress the plunger on the filling syringe to

inject the prescribed fluid into the pump reservoir. While injecting the prescribed fluid, verify that the needle remains properly located within the reservoir.

a. Periodically withdraw and observe a portion of the drug to confirm

that the drug has the expected appearance.

b. After confirming that the needle remains in the reservoir, resume

injecting fluid. Refer to Figure 11 (arrows indicate fluid flow). Maintain light pressure on the filling syringe plunger during the filling

fluid flow).

process.

Syringe with prescribed fluid

Filter

Open clamp

Te mp l at e

Reservoir fill port

Figure 11. Open the clamp and inject into the pump reservoir.

10.

Close the clamp and repeat steps 8 – 9 until the syringe with prescribed fluid is empty.

11. When filling is complete, close the clamp, release the pressure on the

filling syringe plunger, and carefully remove the needle from the reservoir fill port.

2017-06-01 English 25

Note: If you are unsure whether drug was injected correctly into the

pump, completely aspirate the pump to verify that all of the injected drug can be removed.

12. Remove the cleansing agent from the patient’s skin using an alcohol

pad.

13. Apply an adhesive bandage, if desired.

14. Discard all components of the kit.

Reservoir rinse procedure

Performing a reservoir rinse

To prevent drug overdose or underdose when changing concentrations or changing solutions in the pump reservoir, always rinse the reservoir twice between solutions to remove the drug that remains in the reservoir after emptying the pump. This remaining volume is known as the residual volume.

The procedure for performing a reservoir rinse is outlined below. Use the components of the appropriate refill kit to perform the rinse and follow the applicable empty and refill procedures for that kit.

1. Empty the pump completely.

2. Fill the pump with 10 mL of sterile preservative-free Sodium Chloride

Injection, USP.

3. Empty the pump completely.

4. Repeat steps 2 and 3.

5. Fill the pump to capacity with the prescribed fluid.

6. For programmable infusion pumps, program a bridge bolus. Refer to the

programming guide for the pump software.

Calculations for IsoMed pumps (fixed rate) only

Note: Flow rate is affected by changes in altitude and temperature. The

viscosity of the infusion solution as well as the arterial pressure at the location of the catheter tip in vascular applications can also affect flow rate. Refer to "Calculating flow rate" on page 28, to determine the significance of the change.

Scheduling a refill

A refill appointment should be scheduled with your patient. Before scheduling the appointment, calculate the number of days before the reservoir will need to be refilled (Refill Interval).

Caution: At refill the pump should contain at least 2 mL of fluid. The flow

rate of the pump decreases rapidly and stops as the volume in the reservoir decreases from 2 mL to 0 mL. This can result in the potential loss of therapeutic effect or drug withdrawal symptoms.

1. Calculate the refill interval.

Fill Volume (mL) - 2 mL Refill Interval (days)

Flow Rate (mL/day)

Example:

Fill Volume: 20 mL

Flow Rate: 0.5 mL/day

20 mL - 2 mL

0.5 mL/day

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36 days=

Note: The patient should be scheduled to return within 36 days.

2. Schedule the refill appointment with your patient.

Calculating the time required for the drug to advance to the catheter tip

When the pump is emptied and refilled with a change in concentration or a change in solution, it is important to calculate the time required for the new solution to advance to the catheter tip. The time required for the new solution to advance from the reservoir to the catheter tip is calculated based upon the volume of fluid in the implanted catheter and pump tubing. Four values are needed for the calculation: catheter volume per length, implanted catheter length, pump internal volume, and flow rate.

1. Calculate the flow rate in µL/hour.

Flow Rate (mL/day) x 1000 µL/mL Flow Rate (µL/hour)=

24 hours/day

2. Calculate implanted catheter volume in µL.

Implanted Catheter Length

(cm)

3. Calculate the time required for drug to advance to the catheter tip in

hours.

Catheter Volume per Length

(µL/cm)

Implanted Catheter Volume

(µL)

Implanted Catheter Vol u me (µL)

Flow Rate (µL/hour)

Example:

Pump Model Number: 8472-20-10

Labeled Flow Rate: 1.0 mL/day Pump Internal Volume: 300 µL Implanted Catheter Length: 65 cm Catheter Model Number: 8711 Catheter Volume: 2.22 µL/cm

1.0 mL/day x 1000 µL/mL

24 hours/day

2. 65 cm x 2.22 µL/cm = 144 µL

Pump Internal Vol u me (µL)

Time Required for

Drug to Advance (Hours)

42 µL/hour=

2017-06-01 English 27

144 µL + 300 µL

42 µL/hour

Note: The pump internal volume (internal tubing volume) for all models

of the IsoMed pump is 300 μL.

10.5 hours=

Calculating flow rate

The actual flow rate of the IsoMed pump may vary from the labeled flow rate due to different environmental conditions, drug therapies, and routes of administration. The flow rate is affected by changes in altitude and temperature. The viscosity of the drug solution and the body fluid pressure at site of delivery also affect flow rate.

For intrathecal applications, the average clinically measured flow rate

▪

accuracy was 99% of the labeled flow rate (90% confidence interval of 96%-100%) for intrathecal delivery of analgesics (106 patients).

For intravascular applications, the average clinically measured flow rate

▪

accuracy was 91% of the labeled flow rate (90% confidence interval of 88%-91%) for intrahepatic arterial delivery of chemotherapy with 1000 units/mL of heparin (67 patients).

If the patient will be exposed to environmental conditions that differ from typical conditions of use, or if the patient or therapy requires precise knowledge of the labeled flow rate, refer to "Flow Rate Accuracy" in the pump technical manual to determine the impact of these variables on the flow rate.

Calculating infusion solution

The infusion solution consists of the drug and sterile saline, mixed or diluted according to the procedure that follows.

1. Calculate the number of days until the pump is empty.

Reservoir Volume (mL)

Flow Rate (mL/day)

Days Until Pump is Empty

(days)

2. Calculate amount of drug required in mg.

Days Until Pump is Empty (days)

3. Calculate volume of drug required in mL.

Amount of Drug Required

(mg)

Drug Concentration

(mg/mL)

4. Calculate the volume of sterile saline required in mL.

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Prescribed Daily Drug Dose (mg/day)

Amount of Drug

Required (mg)

Volume of Drug Required (mL)

Reservoir Volume (mL)

Example:

Pump Model Number: 8472-20-10

Labeled Flow Rate: 1.0 mL/day Reservoir Volume: 20 mL Prescribed Drug: Morphine Prescribed Daily Drug Dose: 4.0 mg/day Drug Concentration: 10 mg/mL

Volume of Drug Required (mL)

Volume of Sterile Saline

Required (mL)

2. 20 days x 4.0 mg/day = 80 mg of morphine

4. 20 mL - 8 mL = 12 mL of sterile saline

20 mL

1.0 mL/day

80 mg

10 mg/mL

20 days=

8 mL of 10 mg/mL morphine=

Calculating IsoMed pump flow rate accuracy

If the actual volume withdrawn when emptying the pump varies significantly from the expected volume, verify that the Refill Interval has not been exceeded and calculate the flow rate accuracy. If the flow rate accuracy differs significantly from the expected (labeled) rate, taking into consideration the environmental and therapy factors that may affect the flow rate, contact your Medtronic representative.

Calculate flow rate accuracy according to the procedure that follows.

1. Calculate the expected dispensed volume in mL.

Expected Dispensed Volume (mL)

Expected Vol u me (mL)

Days Since Refill (days)

2. Calculate the expected volume in mL.

Refill Volume (mL)

Flow Rate (mL/day)

Expected Dispensed Vol u me (mL)

2017-06-01 English 29

3. Calculate the flow rate accuracy.

Refill Vol u me (mL)

Example: Underinfusion

Actual Volume: 12 mL

Days Since Refill: 16 days Refill Volume: 20 mL Flow Rate: 1.0 mL/day

1. 16 days x 1.0 mL/day = 16 mL

2. 20 mL - 16 mL = 4 mL

Actual Vol u me (mL)

Expected Vol u me (mL)

=x 100-

Flow Rate Accuracy (%)

20 mL - 4 mL

Example: Overinfusion

Actual Volume: 4 mL

Days Since Refill: 10 days Refill Volume: 20 mL Flow Rate: 1.0 mL/day

1. 10 days x 1.0 mL/day = 10 mL

2. 20 mL - 10 mL = 10 mL

3. 20 mL - 10 mL

50%=x 10020 mL - 12 mL

160%=x 10020 mL - 4 mL

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:

Proceed immediately to the next step.

(eg, pocket fill)

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 the 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.

see naloxone package insert.

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

diagnosis of narcotic-induced toxicity should be questioned.

a,b

For continuous IV infusion,

a,b

Notify patient’s physician managing intrathecal pain therapy.

Figure 12. Morphine intrathecal/epidural overdose emergency

Preservative-free morphine sulfate sterile solution manufacturer's

package insert.

procedures.

2017-06-01 English 35

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 13).

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.)

Septum

Needle

Bottom of the reservoir fill port

Figure 13. View inside of a SynchroMed programmable pump while the

needle is fully and properly inserted.

Subcutaneous tissue

2017-06-01 English 37

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 8555 Refill Kit is designed to be used for refilling Medtronic implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps. Medtronic cannot warrant or guarantee the refill kit because, despite the exercise of all due care in design, component selection, manufacture, and testing prior to sale, the components of the refill kit may be easily damaged before or during use by improper handling or other intervening acts.

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Medtronic® Neuromodulation MODEL 8555 REFILL KIT

LIMITED WARRANTY

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

of the Medtronic Model 8555 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 (b) 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 the 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, FAILURE OR MALFUNCTION 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 patient specific legal rights. The patient may also have other rights which vary from state to state.

(4) No person has any authority to bind Medtronic to any representation,

condition or warranty except this Limited Warranty.

(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.

2017-06-01 English 39

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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 P/L 5 Alma Road Macquarie Park 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.

*M221382A014*

M221382A014

Medtronic 8555 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

For SynchroMed pump

Sterilization

Preliminary procedures

Emptying the SynchroMed pump

Refilling the SynchroMed pump

Programming the SynchroMed pump

After the refill procedure

For IsoMed pump

Sterilization

Preliminary procedures

Emptying the IsoMed pump

Refilling the IsoMed pump

Reservoir rinse procedure

Performing a reservoir rinse

Calculations for IsoMed pumps (fixed rate) only

Scheduling a refill

Calculating the time required for the drug to advance to the catheter tip

Calculating flow rate

Calculating infusion solution

Calculating IsoMed pump flow rate accuracy

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