Healthcare Professionals

SynchroMed II Drug Infusion Pump

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. With the implementation of diamond-like carbon coating (DLC), we have now completed SynchroMed II design changes to improve performance. 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


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.
  • The chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity. 

PRODUCT DETAILS

design changes now implemented 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 by an empty reservoir, end of service, motor stall, tube set interval, and critical pump memory error
  • Noncritical alarms sound for a low reservoir, the elective replacement indicator, and noncritical pump memory error

CONVENIENCE

  • Critical therapy and patient data stored in the pump allow flexibility for follow-up at other institutions
  • 180-day drug stability for preservative-free morphine
  • N'Vision™ clinician programmer offers an intuitive touchscreen and user-friendly software

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™ Intrathecal Catheter Models 8780 and 8781
  • Intrathecal Catheter Model 8731SC
  • N'Vision Clinician Programmer
  • myPTM™ Personal Therapy Manager

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.


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

*

Under specific conditions. Refer to product labeling for the full list of conditions.

Requires interrogation to confirm pump status.


1

Medtronic data on file