USA- Massdevice.com writes that the medical device manufacturer Medtronic has recalled specific models of its implantable drug infusion pumps after learning that the devices can malfunction. The SynchroMed II pain pumps have stalled in some patients. The company determined that a foreign particle was in some of the motor assemblies of the devices and that the company has now fixed the problem. The stall will prevent the device from working and can cause the patient to experience pain and potentially go into withdrawal.
The recall impacts Models 8637-20 and 8637-40, with manufacturing dates between May 4, 2018, and April 5, 2019.
The voluntary recall included an urgent field notice to the medical community. Certain patients, such as those using the device to administer intrathecal baclofen, can suffer from potentially life-threatening withdrawal symptoms.
Patients who have chronic pain, cerebral or spinal spasticity often use these pumps as part of their treatment. There have already been hundreds of lawsuits related to the pumps malfunctioning in patients.
This recall is in response to a new complication with the devices. However, Medtronic’s pumps were previously failing as a result of a filmy substance that was forming in the battery and causing the pumps to stop working. The company had 55 reports as of May of 2011 about the devices failing, including one instance that resulted in a fatal case of baclofen withdrawal.
So far, the FDA has not classified this recall. Medtronic’s recall does not indicate that the pumps that are already in patients must be replaced to avoid complications.
Patients who have the SynchroMed II pain pump should discuss the recall with their medical provider and report any complications with the devices.
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