Medtronic has issued four medical device notifications over concerns with its SynchroMed Implantable Infusion System. The notifications are intended to help physicians mitigate the risk of adverse events that may be associated with the device. According to the company, the drug-delivery device is associated with 14 patient deaths.
Three of these notifications were classified as Class I recalls by FDA regulators. Medtronic has suggested that patients using the SynchroMed system maintain regular follow-up visits with their physicians. If the symptoms of their disease change, patients are recommended to contact a physician immediately. If an alarm on the device sounds, patients are asked to contact medical assistance as quickly as possible.
The company’s intrathecal drug delivery device is designed for the treatment of severe pain and muscle spasticity of spinal or cerebral origin. The notifications don’t impact the company's external insulin pumps.
On the SynchroMed Implantable Infusion System, the priming bolus function can lead to improper fluid mixing. The priming polus is designed to move a pharmaceutical to the catheter tip from the SynchroMed pump reservoir, as part of the initialization of intrathecal drug delivery. However, the priming bolus can mix sterile water / cerebrospinal fluid and the pharmaceutical. This can lead to unintended drug delivery. Depending on how the drug mixes with fluids, this can lead to a drug overdose or underdose. The device is also subject to electrical shorts under some conditions. Another issue can lead to a “pocket fill” inadvertent injection during refill procedures. Customers have been instructed to isolate the affected devices and contact Medtronic for more information.
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