Medtronic has been forced to recall its SynchroMed II and SynchroMed EL Implantable Infusion Pain Pumps. The FDA has announced that the recall is a Class I recall, which means that use of the pumps can result in serious injury or death.
The pumps were used to treat cancer, chronic pain, and spasticity. The pumps are designed to deliver medications to a specific site inside a patient's body. The FDA released an alert on March 14, which announced that the pumps could cause the unintended delivery of a large dose of drugs during a certain procedure. The problem could result in an overdose or underdose of the drug, which could lead to a coma or even death.
Medtronic informed its customers of the problem in September 2016. According to Medtronic, the problem with the pumps was due to a software issue. In October, Medtronic began visiting customers in order to replace their software application cards with an updated version. It's unclear if the software problem with the pumps caused any serious injuries or deaths.Unfortunately, defective medical devices are common. Many of them are implanted and can require surgery to correct. Patients who are harmed because of defective medical devices, either because they malfunction or because they require surgery to replace, can receive compensation from the device manufacturer. If you have been harmed by a defective medical device, call the personal injury attorneys at Kennedy Hodges at 855-947-0707. They can help. Call today to learn more or to schedule a free consultation, or visit their YouTube channel