SynchroMed® II and SynchroMed EL Implantable Drug Pumps

Notice type: Advisory

Date: 11/07/2013


Product name or type:
SynchroMed® II and SynchroMed EL Implantable Drug Pumps


Manufacturer Or Supplier:
Medtronic Limited

Target Audience:
Medical directors 
Pain Consultants 
Spinal Surgeons 
Chronic Pain teams 
Theatre teams 
Risk managers 
Emergency Medicine Departments

Problem Or Issue:
Four communications to help identify and manage issues that may impact the safe delivery of therapy using the SynchroMed® II and SynchroMed EL Implantable Drug Pumps.

Background Information Or Related Documents:
Medtronic has recently issued four Field Safety Notices (FSN) related to the SynchroMed II and SynchroMed EL implantable drug pumps and accessories: 

The first FSN (FA573) relates to the priming bolus function. Medtronic has identified that when the priming bolus is used, unintentional mixing of drug and non-drug fluids (including cerebrospinal fluid and sterile water) can occur which can pose a risk of overdose or underdose. Detailed advice on the management of patients during pump priming is provided in appendix 1. 

The second FSN (FA574) relates to a potential electrical short circuit issue that can occur. This issue can result in a motor stall or low battery reset / alarm which in turn may result in an underdose of medication. Underdose of drug can lead to loss of/or reduction in therapy which may cause underlying symptoms and/or withdrawal symptoms. This can create a life-threatening condition for patients receiving intrathecal baclofen therapy. Detailed advice on the management of patients is provided in appendix 2. 

The third FSN (FA578) advises clinicians of an update to the product labelling. Important reminders are provided concerning the potential for a pocket fill during a SynchroMed implantable drug pump refill procedure. Detailed advice is provided in appendix 3. 

The fourth FSN (FA579) confirms the recall of certain ‘Sutureless Connector Intrathecal Catheter Products’ which may exhibit a greater potential for misalignment and subsequent occlusion at the catheter to pump interface. Details of the recall and how to identify devices are outlined in appendix 4.

SynchroMed® II and SynchroMed EL Implantable Drug Pumps Document

Actions To Be Taken:
The IMB recommends that: 

1. Relevant personnel in your organisation are made aware of these potential issues. 
2. The device and patient management advice outlined in the Medtronic Communications is followed. 
3. Unused sutureless connector catheters with a used by date prior to 25th August 2014 should be returned to Medtronic. 
4. This IMB Safety Notice and the attached Field Safety Notices are passed on to any organisation or end user where the potentially affected devices have been transferred.

Further Information:
All adverse incidents relating to a medical device should be reported to the: 

Health Products Regulatory Authority 
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 

Telephone: +353-1-6764971 
Fax: +353-1-6344033 

Enquiries to the manufacturer should be addressed to: 

Medtronic Ireland Ltd, 
Unit G 
Swords Business Campus 
Balheary Road 
Co. Dublin 

Telephone: 01 511 1400 
Fax: 01 807 7220 
Contact person: Lezlie Bridge 

Please click here to view a PDF version of this Safety Notice

Please click here to view Appendix 1

Please click here to view Appendix 2

Please click here to view Appendix 3

Please click here to view Appendix 4

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