Safety Alert for SynchroMed Implantable Infusion Pump

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Medtronic Limited.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

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  • Type of Event
    Safety alert
  • Date
  • Event Date Posted
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: medtronic synchromed implantable infusion pump the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning synchromed implantable infusion pump, manufactured by medtronic. the synchromed priming bolus function is intended to quickly advance drug from the pump reservoir to the catheter tip to allow for therapy initiation while the patient remains under medical supervision. although drug is not intended to be delivered to the cerebrospinal fluid (csf) during the priming bolus, mixing of the drug and non-drug (sterile water/csf) fluids occurs at the high infusion rates used during a priming bolus. mixing results in the unintended delivery of drug prior to the end of the programmed bolus, as well as dilution of some of the drug remaining in the catheter at the end of the bolus. patients will receive unintended drug at a high rate of infusion in the csf during the priming bolus, and a period of reduced concentration of drug will occur following the priming bolus. medtronic has performed preliminary bench testing of pumps and catheters to characterize the extent of drug mixing during a priming bolus. it is clear that the amount of drug delivered during the priming bolus procedure is related to the concentration of the drug; however clinical relevance is not fully understood. as part of the evaluation of the priming bolus, medtronic also reviewed previously reported adverse events of overdose, underdose, and death following an infusion system implant or revision. since drug mixing will occur any time the priming bolus is used with a synchromed pump, it is reasonable to expect that the resulting unintended drug delivery is a contributing factor to adverse events involving overdose and underdose. these adverse events will vary depending on the drug being infused, but could include lack of therapeutic effectiveness, confusion or altered mental state, sleepiness, nausea, respiratory depression, coma or death. medtronic recommends the following published guidance for managing all patients with intrathecal therapy: continue use of the priming bolus procedure to ensure that therapy is initiated while the patient is under medical supervision. monitor all patients following start or restart of intrathecal therapy, as recommended in their field safet notice. the post-procedure monitoring period will depend upon specific drug, dose administered and patient co-morbidities. consider priming the pump prior to implant in the patient and before connection to the catheter (back table prime) to decrease the risk of overdose, especially in patients receiving higher concentration opioid drug solutions and low total daily dose. educate caregivers and family members to recognize the signs and symptoms associated with intrathecal drug therapy complications. patients who are receiving intrathecal baclofen and who receive a catheter-only priming bolus with or without a cap aspiration will take longer to reach full intended drug concentration. dose titration may need to be supplemented with oral baclofen to treat spasticity until the optimal intrathecal dose is obtained. physicians should advise patients to avoid using concomitant drugs that may cause respiratory or cns depression while intrathecal therapy is being initiated or resumed. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con286760 if you are in possession of the product, please contact your supplier for necessary actions. posted on 17 june 2013.


  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic SynchroMed Implantable Infusion Pump
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • 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