Medtronic SynchroMed II implantable infusion pump

Related information

Update - additional information

5 December 2016

Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, has issued an updated hazard alert for the SynchroMed II implantable infusion pump regarding the known issue of over-infusion. The hazard alert provides updated information regarding contributing causes, occurrence rate and patient management recommendations.

Investigation of this issue has not identified any single factor that causes this over-infusion, rather an interaction of several factors can increase the likelihood that a given pump will over-infuse.

Some of these risk factors relate to clinical use conditions, such as use of non-indicated drug formulations, over-filling of the pump reservoir, operation of the pump with no fluid in the reservoir, catheter blockage and pump stops/motor stalls lasting more than 48 hours.

The updated estimated occurrence rate is less than 0.14% (approximately 1 in 700). Five occurrences have been reported in a prospective, long-term multi-centre registry study. In each of these cases over-infusion was associated with pumps being used to infuse drug formulations that were not indicated for use with this device.

The 'Information for consumers' and 'Information for all health professionals' provided below remains appropriate.

Patient management recommendations, provided in the 'Information for surgeons and neurologists' section in the previous 28 March 2014 statement below, have been updated to align with the information provided in the new hazard alert.

Medtronic Australasia continues to provide quarterly reports to the TGA regarding the progress being made to comply with the requirements of a Consent Decree initiated in the United States. See the related TGA statement for further information.

Hazard alert - risk of over-infusion

28 March 2014

Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, has issued a hazard alert for its SynchroMed II implantable infusion pump.

Medtronic SynchroMed II infusion pumps are implantable, programmable medical devices that deliver small amounts of medicine directly into the spinal fluid for the treatment of chronic pain or muscle spasticity.

Illustrated image of where the Medtronic SynchroMed II pumps are implantable within the human bodyIt has been identified that Medtronic SynchroMed II infusion pumps have the potential for over-infusion, defined as an infusion rate that exceeds the programmed rate by more than 14.5%. Confirmed cases of over-infusion have occurred with fewer than 4 in 10,000 pumps implanted. If over-infusion occurs, there is a risk of the patient experiencing an overdose. The patient could also experience a return of underlying symptoms and/or withdrawal symptoms if the pump empties earlier than expected.

Information for consumers

Medtronic Australasia has written to surgeons and neurologists who have implanted Medtronic SynchroMed II infusion pumps or are managing patients who have these devices, providing further information regarding the above issues and advice on how to treat affected patients.

Please note, the likelihood of patients experiencing problems associated with this issue is low.

If you or someone you care for has a Medtronic SynchroMed II infusion pump implanted and experiences any unusual symptoms, including confusion, sleepiness, nausea and breathing difficulties, including shallow or slow breathing, you should seek prompt medical attention. If you experience a return of underlying symptoms, such as chronic pain or muscle spasticity, and/or withdrawal symptoms, advise your managing health professional.

If you have any questions or concerns regarding these devices, contact your managing health professional.

Information for all health professionals

If you are treating a patient who has a Medtronic SynchroMed II infusion pump, and they have any questions or concerns about the above issues, refer them to their managing surgeon or neurologist.

Reassure them that, the likelihood of patients experiencing problems associated with this issue is low.

Advise them that, if they experience any unusual symptoms, including confusion or altered mental state, sleepiness, nausea and respiratory depression, they should seek prompt medical attention. If there is a return of underlying symptoms and/or withdrawal symptoms, they should contact their managing surgeon or neurologist.

Information for surgeons and neurologists

Medtronic Australasia has written to surgeons and neurologists who have implanted Medtronic SynchroMed II infusion pumps or are managing patients who have these devices, providing further information regarding the above issues and advice on how to treat affected patients.

At their next scheduled visit, advise patients and caregivers of this issue and to contact you if they experience a return of underlying symptoms and/or withdrawal symptoms. If they experience any unusual symptoms, including confusion or altered mental state, sleepiness, nausea and respiratory depression, they should seek prompt medical attention.

Prophylactic removal of these devices is not recommended.

It is recommended that, at every refill visit, you question and examine the patient for signs and symptoms of overdose, under dose and/or withdrawal. You should follow the labelled refill instructions, so you can detect any discrepancy between the expected volume level and the medicine withdrawn before refilling. You are advised to record the expected and actual volume levels at each refill visit to enable you to identify volume discrepancy over time.

If you identify volume discrepancy of more than 2 mL, investigate other possible causes, including partial pocket fill, self-aspiration and whether the reservoir was not completely filled at the previous refill visit. If over-infusion is strongly suspected, you are advised to clinically monitor the patient and consider pump replacement.

To stop delivery of medicine from a pump suspected of over-infusion, program it to minimum rate or 'Stopped Pump' mode (for a maximum of 48 hours), and remove any remaining medicine from the reservoir.

Reducing the dose and/or concentration will not correct over-infusion because infusion rates may continue to increase over time.

If you have any questions or concerns regarding these issues, phone Medtronic Australasia on 1800 668 670.

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.