Events

Safety Alert Or Field Safety Notices for Implantable drug pumps and accessories

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Medtronic.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2013/042
  • Date
    2013-06-19
  • Event Date Posted
    2014-12-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-implantable-drug-pumps-and-accessories-risk-of-drug-under-or-overdose
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
    Risk of drug under- or overdose due to various issues with these drug pumps.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 (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. Detailed advice on the management of patients during pump priming is provided in FA573.
    The second 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. Detailed advice on setting / interpreting alarms and reading alarm event logs is provided in FA574.
    The third 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. Full details of how to identify devices for return are provided in FA579.Note: 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 implementedAll these FSNs are available on the MHRA website.
  • Reason
    (medtronic) 4 field safety notices concerning these products. (mda/2013/042).
  • Action
    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.SynchroMed II and EL:Prime all new pumps prior to implant in the patient or connection to the catheter to reduce the risk of overdose. Monitor all patients closely after initiation of therapy for up to 24 hours, dependent on specific drug guidelines (see FSN FA573). Avoid the use of concomitant drugs during therapy initiation that may cause respiratory or CNS depression. Consider providing an oral baclofen supplement to patients receiving intrathecal baclofen, until the optimal intrathecal dose is obtained. Reinforce with patients and caregivers information on the various pump alarms (see FSN FA574) 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 FA535) 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 FA579).

Device

Implantable drug pumps and accessories
  • Model / Serial
  • Product Description
    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.
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Manufacturer Address
    Medtronic Ltd Lezlie Bridge Building 9 Croxley Green Business Park Hatters Lane Watford WD18 8WW Tel-07740 899 216 Fax- 01923 225 273Email:    vigilance.eu@medtronic.com
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    MHRA