Implantable drug pumps and accessories: SynchroMed II and SynchroMed EL (all models) Sutureless connector intrathecal catheter products (models 8709SC, 8731SC, 8596SC, 8578) Manufactured by Medtronic.
Risk of drug under- or overdose due to various
• Be aware that Medtronic has recently
issued four Field Safety Notices concerning these products. The MHRA has summarised and prioritised the required actions below.
• Ensure you follow this advice on device
and patient management and, also, the return of sutureless catheter connectors to Medtronic.
All staff who manage patients implanted with drug pumps.
Manufacturer Lezlie Bridge Note: These deadlines are for systems to be in place to take actions and not for the completion of patient follow-up and testing.
Ref: MDA/2013/042
Problem Medtronic has recently issued four Field Safety Notices (FSN) related to the SynchroMed II and SynchroMed EL implantable drug pumps and accessories: 1. The first FSN (Manufacturer reference: ) confirms a serious risk associated with the priming bolus function. Unintentional mixing of drug and non-drug fluids (including cerebrospinal fluid and sterile water) during the priming bolus can pose a risk of overdose. A subsequent risk of underdose exists following administration of the priming bolus. Detailed advice on the management of patients during pump priming is 2. The second FSN () confirms a risk of an electrical short circuit occurring in the feed-through, which provides an electrically insulated path for current to flow from the electronic circuitry to the motor. This issue typically presents itself as a motor stall or low battery reset / alarm and may result in an underdose. Underdose of drug can lead to return of underlying symptoms and / or withdrawal syndrome, a life-threatening condition for patients receiving intrathecal baclofen therapy. Detailed advice on setting / interpreting alarms and reading alarm event logs is provide. 3. The third FSN () has been issued to notify clinicians that the product labelling has been updated to include the advice on pocket fills, which was originally given in an earlier FSN (). 4. The fourth FSN () confirms the recall of certain connectors manufactured before a recent design improvement. These ‘Sutureless Connector Intrathecal Catheter connectors’ may exhibit a greater potential for misalignment and subsequent occlusion, which can lead to an underdose. Full details of how to identify devices for return are provided in . d in March 2012) relating to erroneous end of service messages, which can result in a drug underdose, also remains relevant as the manufacturer’s software solution has not yet been implemented All these FSNs are available on the MHRA website.
Action SynchroMed II and EL:
• Prime all new pumps prior to implant in the patient or connection to the catheter to reduce the risk of
• Monitor all patients closely after initiation of therapy for up to 24 hours, dependent on specific drug
• Avoid the use of concomitant drugs during therapy initiation that may cause respiratory or CNS
• Consider providing an oral baclofen supplement to patients receiving intrathecal baclofen, until the
and on the signs and symptoms of withdrawal due to therapy cessation.
• Continue to monitor patients for the return of baseline symptoms for the life of the implant as this
could indicate pump failure due to an electrical short.
• Continue to follow advice on the management of device erroneous end of service messages
contained within the earlier FSN (see FSN ) until a software upgrade has been installed.
Sutureless catheter products (used with the SynchroMed pump): Return all sutureless connector intrathecal catheter products that have a use by date preceding 25 August 2014 (see FSN ).
Medicines and Healthcare products Regulatory Agency
Ref: MDA/2013/042
Distribution This MDA has been sent to: • Care Quality Commission (CQC) (headquarters) for information • Clinical commissioning groups (CCGs) • HSC trusts in Northern Ireland (chief executives) • NHS boards and trusts in Wales (chief executives) • NHS boards in Scotland (equipment co-ordinators) • NHS England area teams (for information) • NHS trusts in England (chief executives) Onward distribution Please bring this notice to the attention of relevant employees in your establishment. Below is a suggested list of recipients. Trusts CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including: • A&E departments
• Anaesthesia, directors of • Anaesthetic medical staff
• Anaesthetists • Chronic pain teams
• Pain consultants • Spinal surgeons
• Theatres Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only) This alert should be read by: • Hospitals in the independent sector
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting
Contacts Manufacturer Medtronic Ltd Lezlie Bridge Building 9 Croxley Green Business Park Hatters Lane Watford WD18 8WW
Medicines and Healthcare products Regulatory Agency
Ref: MDA/2013/042
England If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2013/042 or 2013/005/031/081/018 Technical aspects Michelle Kelly or Simon Holmes Medicines & Healthcare Products Regulatory Agency Floor 4 151 Buckingham Palace Road London SW1W 9SZ
Tel: 020 3080 7145 or 7240 Fax: 020 8754 3965
For clinical aspects please contact the Clinical Team Medicines & Healthcare Products Regulatory Agency Floor 4 151 Buckingham Palace Road London SW1W 9SZ How to report adverse incidents Please report via our website
Further information about CAS can be found
Northern Ireland Alerts in Northern Ireland will continue to be distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre Health Estates Investment Group Room 17 Annex 6 Castle Buildings Stormont Estate Dundonald BT4 3SQ
How to report adverse incidents in Northern Ireland Please report directly to NIAIC, further information can be found on our website
Further information about SABS can be fou
Medicines and Healthcare products Regulatory Agency
Ref: MDA/2013/042
Scotland Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre NHS National Services Scotland Gyle Square 1 South Gyle Crescent Edinburgh EH12 9EB
Wales Enquiries in Wales should be addressed to:
Improving Patient Safety Team Medical Directorate Welsh Government Cathays Park Cardiff CF10 3NQ
MHRA is an executive agency of the Department of Health
Addressees may take copies for distribution within their own organisations
Medicines and Healthcare products Regulatory Agency
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Implantable drug pumps and accessories: SynchroMed II and SynchroMed EL (all models) Sutureless connector intrathecal catheter products (models 8709SC, 8731SC, 8596SC, 8578) Manufactured by Medtronic.
Risk of drug under- or overdose due to various
• Be aware that Medtronic has recently
issued four Field Safety Notices concerning these products. The MHRA has summarised and prioritised the required actions below.
• Ensure you follow this advice on device
and patient management and, also, the return of sutureless catheter connectors to Medtronic.
All staff who manage patients implanted with drug pumps.
Manufacturer