Introduction
Screening Test
Preoperative Considerations and Care
Programmable Infusion System Implant Procedure
Postoperative Care

Postoperative Care

• Management of complications
• Continued patient education
• Care of operative site
• Titration of drug dose

Please refer to the current SynchroMed Infusion System Technical Manual for a complete list of indications, contraindications, warnings, precautions and adverse events.

• Surgical complications
• System complications
• Adverse drug events
• Other complications

Surgical Complications

Prophylactic antibiotics are recommended for pump implantation. Patients who have poor nutritional status, are small and/or thin, or have generally poor health are at greater risk for post-surgical infections.

• Infection
• Spinal headache
• CSF hygroma
• CSF leakage around catheter insertion site
• Bleeding
• Pain and discomfort
• Pump pocket seroma
• Hematoma

Should any of the above complications occur, they should be managed according to your hospital's policies and procedures, as well as medical and nursing standards of care.

Please refer to the SynchroMed^® Infusion System: Clinical Reference Guide for Pain Therapy-Part Two for Patient Management information related to specific surgical complications (available in the online Library).

System Complications

• Catheter kink
• Catheter obstruction
• Catheter dislodgement, disconnection or breaks
• Programming errors
• Pump failure

System complications may present as drug overdose, loss of drug effect, or withdrawal symptoms. When investigating loss of drug effect, evaluate factors such as disease progression, drug tolerance or concurrent illness. Consult the drug package insert for additional information. If there are no patient-related factors present, then investigate system problems.

Other Complications

In rare instances, the development of an inflammatory mass at the tip of the implanted catheter may occur that can result in progressive clinical signs that bear monitoring. These signs include a progressive change in the character, quality, or intensity of pain; an increase in the level and degree of pain despite dose escalation; sensory changes, i.e., numbness, tingling, burning, hyperesthesia and/or hyperalgesia.

Presentations that require immediate diagnosis include bowel and/or bladder dysfunction; myelopathy, conus syndrome, gait disturbances or difficulty ambulating; and paraparesis or paralysis.

If the presence of an inflammatory mass is suspected, recommended evaluation should include a review of the patient history and neurological evaluation, radiological diagnostic procedures (such as an MRI with contrast), and an appropriate clinical consultation.

Adverse Drug Events

Monitor the patient until you are confident that the patient's response to the drug is acceptable. Watch for adverse drug events and signs of drug overdose. Please consult the drug package insert for additional information.

For more information, see Adverse Events under Important Safety Information and Risks.

Continued Patient Education

Throughout their treatment with intrathecal drug delivery, patients will undoubtedly have questions and concerns. Encourage patients to contact their physician's office as needed. During regularly scheduled visits, plan on a few minutes to answer questions as they occur. The more educated and comfortable the patient is about his or her therapy, the more likely it is that successful results will be achieved. In educating patients for the long-term, be sure they are knowledgeable about the following:

• Symptoms of infection
• Adverse drug effects
• Signs and symptoms of overdose and withdrawal
• Hazards in driving or operating machinery when drowsy
• Potential effects of alcohol and other CNS depressants
• The need to consult their physician before using other medications
• Consequences of letting pump run dry and experiencing withdrawal symptoms

Patient education materials are available from Medtronic upon request.

Observe the drug effects and titrate the dosage as needed to optimize efficacy and minimize adverse effects. Please consult the drug package insert for additional information.

You may also consult with other practicing physicians who have experience with this therapy. Contact your Medtronic representative for information or a referral.

Introduction
Screening Test
Preoperative Considerations and Care
Programmable Infusion System Implant Procedure
Postoperative Care