Medtronic Australasia - US consent decree on SynchroMed drug infusion system

Following the US consent decree described below, the TGA has imposed two new conditions on the inclusion of the SynchroMed II Programmable Pump in the Australian Register of Therapeutic Goods (ARTG ID 97770).

The conditions are that:

1. Medtronic Australasia Pty Ltd (Medtronic) will provide three-monthly reports on progress that Medtronic Inc is making with complying with the requirements set out in the consent decree between the United States of America and Medtronic Inc and S. Omar Ishrak and Thomas M. Tefft filed in the United States District Court for the District of Minnesota on 27 April 2015 (the consent decree). The first report is due on 1 November 2015 and is to cover the period 1 July 2015 to 30 September 2015 (inclusive).  Reporting will continue for a minimum of three years ending with the report covering the period 1 July 2018 to 30 September 2018. 
2. Medtronic will inform the TGA as soon as practicable after the relevant information comes to its notice:
   1. of any orders issued by the United States Food and Drug Administration (USFDA) under paragraph 11 of the consent decree to Medtronic Inc in relation to the development and implementation of the Pump Remediation Plan (as referred to in paragraph 7.C of the consent decree),
   2. of any data or information arising from the development or implementation of the Pump Remediation Plan, or in relation to any other matter arising from the implementation of the consent decree, that might have implications for the safety and/or performance of the devices supplied in Australia,
   3. of any other orders issued by the USFDA under paragraph 11 of the consent decree requiring Medtronic Inc to undertake particular actions in relation to the device, including any of the actions referred to in that paragraph,
   4. of any action taken by the USFDFA under paragraph 13 if the consent decree in relation to the device, and
   5. of any notification by USFDA to Medtronic Inc that it is compliant as per paragraph 6 of the consent decree.

The conditions took effect on 1 July 2015.

The decision to impose these conditions is open to review under the Therapeutic Goods Act 1989. Medtronic Australasia has 90 days from the date on which it was notified of the decision to request such a review.

US consent decree

28 May 2015

The TGA is aware of regulatory action undertaken by the US Food and Drug Administration (FDA) in relation to the SynchroMed drug infusion system.

The SynchroMed drug infusion system involves an implantable, programmable pump that delivers small amounts of medicine directly into the spinal fluid for the treatment of chronic pain or muscle spasticity. The system is supplied in Australia by Medtronic Australasia.

Under a consent decree the FDA has directed the US parent company Medtronic Inc to complete certain corrections and enhancements to the SynchroMed drug infusion system pump and the Neuromodulation quality system and to introduce a certification process for continued supply of pumps.

While the standards expected of medical device manufacturers are generally uniform across regulators, different regulatory frameworks can result in different compliance actions being required in different countries. The consent decree requires Medtronic to undertake the required actions globally and Medtronic Australasia will be implementing them in Australia from 15 June.

The TGA is reviewing information supplied by Medtronic Australasia regarding this issue. The TGA will continue to monitor the safety and performance of SynchroMed drug infusion systems and will take appropriate regulatory action if a safety concern becomes apparent. In accordance with its usual procedures, the TGA will also continue to liaise closely with the FDA and other international regulators on this and similar issues.

Information for consumers

Medtronic Australasia has written to health professionals who have implanted a SynchroMed drug infusion system or undertake ongoing patient monitoring to alert them to this issue and advise them of the steps they should take.

Patients presently using the system are not required to take any action. All necessary components will continue to be available.

If you have any questions or concerns about this issue call Medtronic Australasia on 1800 668 670 or email neurosupport.australia@medtronic.com.

Information for health professionals

Medtronic Australasia has written to health professionals who have implanted a SynchroMed drug infusion system or undertake ongoing patient monitoring providing further information about this issue.

Under the consent decree Medtronic may provide SynchroMed drug infusion system pumps as replacements for existing patients and to new patients when a physician certifies that the pump is medically necessary and the benefits of such treatment outweigh the risks.

A certification process provided by Medtronic Australasia will document that the patient meets the required criteria.

Medtronic Australasia will be implementing the requirements of the consent decree from 15 June in Australia and will require health professionals to sign the certificates before ordering a pump.

Components and accessories including catheters, refill kits, catheter access port kits, catheter revision kits and accessory kits will continue to be available.

If you have any questions or concerns about this issue contact Medtronic Australasia on 1800 668 670 or email neurosupport.australia@medtronic.com.

Additional information

The decree requires Medtronic to comply with the FDA's quality system regulation for medical devices and limits Medtronic's ability to manufacture and distribute the SynchroMed drug infusion system unless specific conditions are met. To prevent disruption to patient care, the FDA will allow limited manufacturing and distribution of SynchroMed drug infusion system pumps for currently implanted patients who require a replacement, and for new patients under conditions of medical necessity.

Under the agreement, Medtronic is required to implement a plan to make certain changes to the SynchroMed drug infusion system pump. These will include design changes to address issues previously communicated in medical device correction notices. The agreement also requires Medtronic to engage an independent expert to inspect the Neuromodulation quality system, processes and records, and to obtain the expert's certification that the system is in compliance with the requirements of the decree. Once the compliance of Medtronic Neuromodulation's quality system is certified to the FDA's satisfaction, the limitations on manufacture and distribution of SynchroMed drug infusion system pumps will be lifted.

The consent decree also allows Medtronic to continue to manufacture and distribute components and accessories to support currently implanted SynchroMed drug infusion systems.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.