Device Alert: Medtronic SynchroMed II and SynchroMed EL Implantable Drug Pumps

Medtronic has recently issued four Field Safety Notices (FSN) related to the SynchroMed II and SynchroMed EL implantable drug pumps and accessories. These have been wrapped up into one Device Alert by the UK’s MHRA regulatory authority.

Background

We’ve covered the ills of Medtronic’s Synchromed pain pumps before, going back to September 2011, when defective batteries were the concern. It seems the troubles have not gone away, as the company’s four new Field Safety Notices (FSNs) suggest.

The first FSN (Manufacturer reference: FA573) 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.

Next up, FSN FA574 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.

Thirdly FSN FA578 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 (FA496).

The fourth FSN (FA579) 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.

Finally, an earlier FSN (FA535, issued 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.

So, what to do?

The MHRA Device Alert can be found here, and it contains links to the individual FSNs, which include instructions on what to do next. Actions vary from simple usage instructions through to potential revision to remove or replace pumps.

Source: MHRA