While many medications have potential side effects, taking the medication as prescribed minimizes your chances of experiencing them and suffering harm. Patients who used the Synchromed II pain pump believed it was giving them the proper dosage of pain medications morphine and prialt, the muscle relaxant baclofen, and cancer drugs to treat their conditions safely. But the defective device caused some of them to receive over or under delivery of drugs that could lead to serious injury or even death.

1. Synchromed II: What is it?
Paul Miller

2. About Howie, Sacks & Henry LLP
▪ Ranked one of the top personal injury firms in Canada by
Canadian Lawyer Magazine since 2011.
▪ Lexpert Ranked lawyers.
▪ Lawyers Listed in Best Lawyers in Canada.
▪ Certified Specialists, Civil Litigation.

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Sychromed II: What is it?
▪Programmable infusion pump implanted in the body for drug delivery to
treat chronic pain, spasticity, and primary or metastatic cancer
▪Class III Medical Device
▪Launched 2004
▪Approved for:
–Morphine, Prialt for pain
–Baclofen
–Cancer medication
▪Approximated 260,000 Devices sold Worldwide
▪Manufactured by Medtronic

4. www.hshlawyers.com
Medtronic Synchromed II System Pump
and Connected Catheter
A Catheter is connected to pump
on one end and the other
inserted into the intrathecal
space in the spine
A Catheter Access port (CAP)
allows injection of the drug
directly into the implanted
catheter for drug administration
and diagnostic purposes.

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Sychromed II: How Does It Work?
▪ Delivers medication to a specific site in the body, and
medication is stored in a refillable 20 ml or 40 ml reservoir

6. ▪Drug delivery rate calculated by clinician
and programmed into the pump
▪Catheter is inserted into the infusion
site
▪Pump is surgically inserted into the
abdomen pocket and connected to
other end of catheter
▪Pump is refilled 3-4 times/year by
clinician
▪Battery designed to last up to 7 years, at
which time the pump is replaced
Synchromed II Basics: Programming, Inserting,
and Operating the Pump
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7. Synchromed II: Injuries
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▪Device failure can result in under or over- delivery of drugs
with serious adverse health consequences including:
– Organ failure
– Stroke
– Coma
– Return of spasticity
– Respiratory depression
– Death

8. April 2015: FDA Takes Action
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▪April 27, 2015, DOJ and FDA files consent decree of
permanent injunction and civil complaint filed against
Medtronic.
▪Alleged that Medtronic violated Current Good
Manufacturing Practices (GMP) in its manufacture of pumps
making them “adulterated” products
▪Medtronic failed to correct “significant violations” of FDA
regulations, uncovered during FDA inspections in 2006 and
2013
▪Per the consent decree, Medtronic agreed to suspend
manufacturing and distribution of the SynchroMed II
implantable pumps

9. Thank you for your time. For more information:
Paul Miller, Partner
Howie, Sacks & Henry LLP
Suite 3500, 20 Queen Street West
Toronto, ON M5H 3A3
416-646-3901
pmiller@hshlawyers.com