COVID-19 FAQ FOR PATIENTS

COVID-19 FAQ for patients with a SynchroMed™ II drug pump for chronic pain, malignant pain or severe spasticity

At Medtronic, we understand that this is an uncertain time for many people.  If you are implanted with a SynchroMed™ II drug pump, you may have additional questions about how COVID-19 might impact you. We have created this website to provide you with resources regarding your pump and COVID-19.  

We encourage you to stay connected with your managing physician’s office and confirm any upcoming refill appointments.  We also encourage you to visit the WHO and CDC websites for the latest information on COVID-19, and to be aware of any local requirements related to COVID-19.  

COVID-19 FAQ

Q: I’m quarantined in my home and/or the facility where I get pump refills is restricting access.  How can I find a physician that will come to my home for refill?

  • Refills for drug pumps are not elective procedures. Contact your managing physician’s office weeks ahead of your refill date to discuss options available in your area. Understand it may take days to identify available options and schedule an appointment. Talk to your managing clinician’s office about home infusion services in your area that manage patients with drug pumps if leaving your home is not an option.
  • You can also consider using the Medtronic physician finder that may identify other physicians with the appropriate specialty to assist using the link below:

               Medtronic.com/FindPhysician

Q: I have a pump-refill coming up in the next few weeks, but I’m afraid to go to the hospital because I do not want to be exposed to COVID-19.  What should I do?

It is critical that you keep your scheduled refill appointments so that you do not run out of medication, which can lead to return of symptoms and in some patients, very serious effects that may result in additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug underdose.  Contact your managing physician’s office weeks ahead of your refill date to discuss options available in your area. Understand it may take days to identify available options and schedule them.

If you have not done so already, ask your doctor about any medications you may need if your refill is delayed, obtain the prescriptions and make sure you have those medications available. Ensure you have your prescribed medications available at your home and that you and your caregiver are aware of when and how to take it. Your caregiver should be educated on the early symptoms of withdrawl.

Q: I can’t travel to the hospital or clinic where I normally get my pump refills.  How can I find another managing physician locally?

If you cannot travel to the clinic where you normally receive refills, ask them for a referral to another physician near you and ask them to contact that physician immediately to get the process of scheduling a visit started.  Consider talking to your doctor’s office about home infusion services in your area that manage patients with pumps if leaving your home is not an option.

You can also consider using the Medtronic physician finder that may identify other physicians with the appropriate specialty to assist using the link below:

 Medtronic.com/FindPhysician

Q: I’m in a foreign country and due to travel restrictions, I can’t get back to my home country to get my pump refilled. Can I get a refill in a foreign country?

Medtronic is available worldwide and can help you to identify the nearest possible hospital, clinic or physician to get access to a pump refill in a foreign country. Contact your managing physician, who can work with a Medtronic representative to help you to identify refill options. Please be aware that this might take a few days to investigate so contact your managing physician as early as possible before the refill alarm takes place.

Consider contacting your embassy to get information about returning to your home country.

SYNCHROMED® II DRUG INFUSION SYSTEM BRIEF STATEMENT

Review product technical manuals, including information about EMI, and the appropriate drug labeling prior to use for detailed disclosure.

INDICATIONS

US: Chronic intrathecal infusion of Infumorph® preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, Prialt® chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, and chronic intrathecal infusion of Lioresal® Intrathecal (baclofen injection) for the management of severe spasticity. Outside of US: Chronic infusion of drugs or fluids tested as compatible and listed in the product labeling.

DRUG INFORMATION

Refer to appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration, screening procedures, and under-/overdose symptoms and methods of management. Patients should be informed of the signs and symptoms of drug under- or overdose, appropriate drug warnings and precautions, and signs and symptoms that require medical attention.

CONTRAINDICATIONS

System implant is contraindicated in the presence of an infection; implant depth greater than 2.5 cm below skin; insufficient body size; and spinal anomalies. Use of the system with drugs with preservatives and drug formulations with pH ≤3. Use of CAP kit for refills or of refill kit for catheter access and use of PTM to administer opioid to opioid-naïve patients.

WARNINGS

Non-indicated formulations may contain neurotoxic preservatives, antimicrobials, or antioxidants, or may be incompatible with and damage the system. Failure to comply with all product instructions, including use of drugs or fluids not indicated for use with system, or of questionable sterility or quality, or use of non-Medtronic components or inappropriate kits, can result in improper use, technical errors, increased risks to patient, tissue damage, damage to the system requiring revision or replacement, and/or change in therapy, and may result in additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug under- or overdose.

An inflammatory mass that can result in serious neurological impairment, including paralysis, may occur at the tip of the implanted catheter. Clinicians should monitor patients carefully for any new neurological signs or symptoms, change in underlying symptoms, or need for rapid dose escalation. Monitor patients appropriately after refill if a pocket fill is suspected. Failure to recognize signs and symptoms of pocket fill and seek appropriate medical intervention can result in serious injury or death. Overinfusion may lead to underdose or overdose symptoms. Strong sources of electromagnetic interference (EMI) can negatively interact with the pump and cause heating of the implanted pump, system damage, or changes in pump operation or flow rate, that can result in patient injury from tissue heating, additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug underdose or overdose. The SynchroMed II system is MR Conditional; consult the labeling for MRI information.

PRECAUTIONS

Monitor patients after pump or catheter replacement for signs of underdose/overdose. Infuse preservative-free saline at minimum flow rate if therapy is discontinued for an extended period to avoid system damage. EMI may interfere with programmer telemetry during pump programming sessions.

ADVERSE EVENTS

In addition to procedure-related risks, the following may occur: pocket seroma; hematoma; erosion; infection; pump inversion; post-lumbar puncture risks (spinal headache); CSF leak and rare central nervous system pressure-related problems; radiculitis; arachnoiditis; spinal cord bleeding/damage; meningitis; neurological impairment (including paralysis) due to inflammatory mass; allergic response to implant materials; surgical replacement due to end of service life or component failure; loss of therapy, drug overdose, or inability to program the pump due to component failure; catheter complications resulting in tissue damage or loss of or change in therapy; potential serious adverse effects from catheter fragments in intrathecal space.

For full prescribing information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com Infumorph® is a registered trademark of West-Ward Pharmaceutical. Prialt® is a registered trademark of TerSera Therapeutics LLC. Lioresal® is a registered trademark of Saol.

USA Rx Only
Rev 1118

PRODUCT ADVISORIES

Medtronic has notified physicians about product advisories related to Medtronic Targeted Drug Delivery Systems. This information can be found at medtronic.com.

We are committed to answering your questions, keeping you informed, and continuously improving our products. If you have questions about the advisories, please contact Medtronic Patient Services at 800-510-6735, Monday through Friday, between 8 am and 5 pm, CT.