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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.
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