Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its SynchroMed II Implantable Drug Infusion Pump (Model 8637).
In the past two years, the manufacturer has received eight reports where pump programming sessions were not fully completed and where the patient was released from the clinical setting with infusion therapy stopped. In these events, programmer warning screens notified clinicians of an incomplete programming session, however the programming sessions were not completed. In the reported events, the time to recognize the patient's pump was in stopped mode varied from 48 hours to 21 days. While the reported rate for this issue is very low (0.000517%), the manufacturer is raising awareness of this situation to inform all users. Investigations by the manufacturer have not identified any product defect or issue.
The device is programmed by a patient's healthcare professional using either the 8870 Software Application on the N'Vision Model 8840 Clinician Programmer, or the Model A810 SynchroMed II Software Application on the Clinician Programmer Tablet. During pump update the pump is automatically placed in a stopped pump mode and will restart when the pump update is complete.
Warning screens appear on the programmer when a programming session is incomplete. If these warnings are not addressed and the programming session is not completed, it can result in patients leaving a clinical setting without therapy delivery due to the pump remaining in a stopped pump mode. Of the reported events, five of the eight reported patient harm including one patient developing withdrawal symptoms requiring hospitalisation, and four patients developing withdrawal symptoms and/or return of underlying symptoms requiring out-patient management. Potential harm for patients treated for pain or spasticity indications may include serious or life-threatening injury associated with drug withdrawal and/or a return of underlying symptoms. Physicians must also consider the potential harm due to therapy interruption for patients being treated with off-label indications or off-label drugs.
The labeling (Programming Guides) for both programmers include instructions for programming the pump and warn that incomplete programming sessions can result in the device remaining in stopped pump mode. Additionally, both programmers include on-screen prompts to inform clinicians of situations where incomplete programming may result in the pump remaining in stopped pump mode.
The manufacturer is recommending healthcare professionals who manage patients with the SynchroMed II infusion pump to be familiar with the warnings and cautions within the labeling as well as the warning screens on the programmer.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 8 December 2020