SYNCHROMED II DRUG PUMPS

KEY POINTS

• The SynchroMed™ II drug pump is a battery-powered implantable and programable device that stores and dispenses medication inside the body.
• In 1988, FDA first approved SynchroMed as a Class III medical device for the infusion of drugs to palliatively treat certain types of cancer, pursuant to FDA’s Premarket Approval (PMA) process, the agency’s most stringent medical device review process. The SynchroMed II device was approved in 2003 under the same guidelines. The Synchromed II device can be used to treat chronic pain conditions, including cancer-related pain, and to manage severe spasticity.
• Medtronic continues to monitor the safety of SynchroMed II. In addition to mandated reporting of adverse events to the MAUDE database, Medtronic analyzes occurrence of all adverse events reported to us. Medtronic’s broad scale Product Performance Registry is another source of data that demonstrates reliability of the system and identifies safety improvements for the device.
• Medtronic actively monitors and publishes SynchroMed II pump survivability with use of both on and off-label drugs. Data is publicly available through our Annual Product Performance Report.
• Medtronic continues to improve the design and performance of the SynchroMed II pump. In 2016 and 2017, three durable design changes and one software change were implemented.

Overview

1. Important Option for Treating Intractable Chronic Pain, including cancer-related pain, and Managing Severe Spasticity
   
   

   The SynchroMed II drug pump is a battery-powered implantable and programable device that stores and dispenses medication inside the body. The pump delivers the medicine to the fluid around the spine through a thin, flexible tube called a catheter. A doctor programs the pump to release a certain amount of medication. Both the amount and timing can be adjusted as to the patient’s needs change. The device can be used to treat chronic pain conditions, including cancer-related pain, and to manage severe spasticity of spinal origin (e.g., spinal cord trauma or multiple sclerosis) or cerebral origin (e.g., cerebral palsy).

2. Subjected to the FDA’s Most Rigorous Approval Process
   
   

   In 1988, FDA first approved SynchroMed as a Class III medical device for the infusion of drugs to palliatively treat certain types of cancer, pursuant to FDA’s Premarket Approval (PMA) process, the agency’s most stringent medical device review process. The SynchroMed II device was approved in 2003 under the same guidelines. The SynchroMed II device can be used to treat chronic pain conditions, including cancer-related pain, and to manage severe spasticity.

   The PMA process is the most stringent medical device marketing review process in the United States. It is estimated that FDA spends an average of 1,200 hours reviewing each PMA application.¹ FDA grants premarket approval for Class III devices only if it finds there is sufficient valid scientific evidence to show that the device meets the appropriate risk/benefit ratio for its intended use.

3. Safety Monitoring
   
   

   Medtronic continues to monitor the safety of SynchroMed II. In addition to mandated reporting of adverse events to the MAUDE database, Medtronic analyzes occurrence of all adverse events reported to us. Medtronic’s broad scale Product Performance Registry is another source of data that demonstrates reliability of the system and identifies safety improvements for the device.

   In 2004, Medtronic initiated an FDA-approved 12-month, multi-center, single arm prospective post-approval study for SynchroMed II to determine flow-rate accuracy and safety over 12 months. Medtronic submitted and received FDA approval for labeling updates based on this study. The final safety findings were also published in a medical journal, Regional Anesthesia and Pain Medicine. The authors concluded, “the SynchroMed II pump accurately and safely delivered intrathecal medications in the clinical setting of this study.”²

   Additionally, we’re currently running another post-approval study in Europe. Medtronic also maintains a Product Performance Registry where it posts annual reports monitoring the performance of its products. This prospective, long-term multi-center registry contains insights collected from more than 7,400 targeted drug delivery system patients at 60 centers worldwide who were enrolled between August 7, 2003 through July 31, 2016, and collection of this data continues. The Registry is used to monitor and investigate performance and adverse event trends and to collect and analyze data that drives product enhancement and innovations.

4. Continued Innovation of SynchroMed II
   
   

   Medtronic continues to improve the design and performance of the SynchroMed II pump. Three durable design changes and one software change were implemented in 2016 and 2017. Medtronic continues introducing new innovations in drug infusion technology. In January, 2018 we announced FDA approval of a new tablet-based clinician programmer to simplify therapy management by providing physicians with visual tools and intuitive workflows. On July 31, 2018, FDA approved a new SynchroMed II myPTM™ Personal Therapy Manager for patients with chronic pain. myPTM works with SynchroMed II drug pump and further allows patients to personalize their therapy to alleviate unpredictable pain. “Pain is very personal and can be unpredictable,” said John A. Hatheway, M.D., owner and provider at Northwest Pain Care in Spokane, Washington. “The Medtronic pain pump and myPTM are powerful tools to safely treat chronic pain including intractable cancer pain."

5. U.S. FDA Consent Decree
   
   

   Medtronic continues to meet its obligations under the U.S. consent decree related to the SynchroMed II system. Since early 2016, we’ve implemented a series of design changes to the SynchroMed II system intended to increase performance and safety, including improvements aimed at reducing motor stalls and the potential for over-delivery of drug in the initial 24 hours of therapy.

   We’ve also made improvements across our Quality Management System (QMS), resulting in achieving substantial compliance noted through a series of inspections by an independent expert and FDA.

   The previous requirements for obtaining certificates of medical necessity prior to distributing the SynchroMed II system were lifted in the U.S. in Fall 2017 and have been lifted in all countries outside the U.S. as well. This was an important milestone that allowed access to patients who depend on Intrathecal drug delivery as an option for the treatment of chronic, intractable pain or severe spasticity.

IMPORTANT SAFETY INFORMATION

SynchroMed II Drug Infusion System Brief Statement

Product technical manuals and the appropriate drug labeling must be reviewed 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 or to administer ziconotide.

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 of time to avoid system damage. EMI may interfere with programmer telemetry during pump programming sessions. EMI from the SynchroMed programmer may interfere with other active implanted devices (e.g., pacemaker, defibrillator, neurostimulator).

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 Jazz Pharmaceuticals plc or its subsidiaries. Lioresal^® is a registered trademark of Saol.

USA Rx Only

Rev 0817

PRODUCT ADVISORIES
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Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.