Healthcare Professionals

SynchroMed II Drug Infusion System

Targeted Drug Delivery

Overview

The Medtronic SynchroMed™ II pump is part of the SynchroMed II programmable infusion system that stores and delivers pain medication into the intrathecal space, according to instructions programmed by the clinician. The pump and catheter are implanted under the skin.

Medtronic has implemented four design changes to improve the design and performance of the pump, such as the application of diamond-like carbon coating (DLC). DLC is a highly durable, thin coating applied to SynchroMed II motor shafts to prevent wear. This change is projected to address over 99% of shaft wear, decreasing the occurrence of motor stalls.1

The SynchroMed II Pump is programmable by the Clinician Programmer, which features visuals, workflow guides, a vibrant backlit screen, and a wireless communicator to help simplify programming.


INDICATIONS

Within the United States:

  • The chronic epidural/intrathecal infusion of Infumorph™ (preservative-free morphine sulfate sterile solution) in the treatment of chronic intractable pain.
  • The chronic intrathecal infusion of Prialt® (preservative-free ziconotide sterile solution) for the management of severe chronic pain.

PRODUCT DETAILS

SYNCHROMED II CLINICIAN PROGRAMMER

SYNCHROMED II CLINICIAN PROGRAMMER
  • Tablet with touchscreen interface compatible with the SynchroMed™ II pump 
  • Helpful workflow guides and simple steps for refill and implant 
  • Built-in auto-calculations for volume and rates 
  • Visuals accompany prime bolus and flex dosing to help simplify the process 
  • Communicator and the programmer are designed to wirelessly connect enabling flexible and comfortable delivery of patient care within 3 meters

SYNCHROMED II PUMP DESIGN CHANGES TO IMPROVE PERFORMANCE1

In Pumps Returned and Analyzed for Motor Stall:1

What We've Done:1 
Shaft wear is observed in 59% Applied Diamond-like Carbon Coating to Shaft
Projected to address over 99% of shaft wear (Implemented in 2017)
Corrosion of the drive gear is observed in 2% Modified the GearWheel Material
Projected to address over 93% of corrosion of the drive gear (Implemented in 2016)
Internal shorting is observed in 14% Encapsulated the Feedthroughs
Projected to address over 96% of internal shorting (Implemented in 2016)

The implementation of these three design changes DOES NOT IMPLY an equivalent percent reduction in motor stall.

DESIGN ENHANCEMENTS DRIVEN BY REAL-WORLD DATA

Data driving the four design enhancements came from:

  • Active monitoring of SynchroMed II performance through the Product Performance Registry
  • Monitoring and investigating complaints and complaint trends
  • Data analysis to drive product enhancements and innovations

Overall reliability of the SynchroMed II pump is 91% at 6 years.2

SynchroMed II chart

BENEFITS

PROGRAMMABILITY

  • Flex dosing schedules allow drug delivery to be matched to patient needs, providing chronic pain relief throughout the day
  • Precise dose titration enables clinicians to prescribe the lowest dose to reach patient goals

SAFETY

  • Smart software guides the clinician through programming the system, via information and warning screens
  • Full body MRI compatibility at 1.5 and 3-Tesla under specific conditions*
  • Critical alarms are triggered at end of service, if a motor stall is detected, critical pump memory error, tube set interval, or if an empty reservoir is estimated.
  • Noncritical alarm sounds for the elective replacement indicator, noncritical pump memory error, or a low reservoir is estimated.

CONVENIENCE

  • Critical therapy and patient data stored in the pump allow flexibility for follow-up at other institutions
  • 180-day drug stability for Infumorph™
  • Clinician programmer features a vibrant touchscreen display, visuals, and workflow guides
  • The communicator is placed over the pump and is designed to wirelessly connect within 3 meters of the clinician programmer

HOW IT WORKS

The drug enters the pump through the reservoir fill port and passes through the reservoir valve and into the SynchroMed II pump reservoir. At normal body temperatures, pressurized gas that is stored below the reservoir expands, exerting constant pressure on the reservoir. This pressure advances drug into the SynchroMed II pump tubing.

The peristaltic action of the SynchroMed II pump moves the drug from the pump reservoir, through the pump tubing, check valve, catheter port, and implanted catheter, to the infusion site.

The catheter access port (CAP) allows injection of the drug directly into the implanted catheter for drug administration and diagnostic purposes. Drug injected into the CAP bypasses the SynchroMed II pump mechanism and goes directly through the catheter port into the implanted catheter to the infusion site.

Ports and suture loops on the SynchroMed II infusion pump

ACCESS TO MRI

Implanting the SynchroMed II infusion pump under the appropriate conditions will not restrict patients from receiving a full body MRI scan. The SynchroMed II infusion system allows safe full-body access to 1.5 and 3.0-Tesla MRI.* The pump is designed to resume programmed therapy after the scan.


COMPATIBLE PRODUCTS

Ascenda catheter

ASCENDA CATHETER

  • Available in 2 lengths
  • Flexible and trimmable
  • Unique four-layer construction for compression resistance
  • Sutureless connector

myPTM PERSONAL THERAPY MANAGER

myPTM PERSONAL THERAPY MANAGER
  • Optional device for use with the SynchroMed II pump
  • Approved for self-administration of morphine within physician set limits
  • May benefit patients who have:
    • Uncontrolled intermittent pain of varying intensity
    • An unpredictable need for varying doses of medication
    • A desire to reduce or eliminate systemic opioid consumption

MANUALS AND TECHNICAL GUIDES

Access prescriber, implant, MRI, and other manuals on the Medtronic Manual Library Search by the product name (SynchroMed) or model number (8637). You may also call 800-961-9055 for a copy of a manual.


SynchroMed Pump MODEL SPECIFICATIONS

Model 8637-20 (20 mL reservoir) 8637-40 (40 mL reservoir)
Battery Life 4 to 7 years 4 to 7 years
Weight (empty/full) 165/185 g (5.8/6.5 oz) 175/215 g (6.2/7.6 oz)
Thickness 19.5 mm (0.78 in) 26 mm (1.0 in)
Minimum flow rate 0.048mL/day 0.048mL/day

*

MR Yellow Triangle  Under specific conditions for 1.5 T and 3.0 T MRI scans. Requires interrogation to confirm pump status.

Requires interrogation to confirm pump status.


1

Medtronic data on file