Proclaim XR (spinal cord stimulant)

2023: Recall of defective implants due to faulty Bluetooth

On September 13, 2023, the U.S. Food and Drug Administration (FDA) announced the recall of defective neurostimulation implants manufactured by Abbott. The defect causes the devices to fail, as a result of which additional surgery may be required to remove the product and replace it with a new one.

Recall affects products such as Proclaim XR 5 IPG Model 3660 (formerly Proclaim 5 Elite IPG Model 3660), Proclaim XR 7 IPG Model 3662 (ранее — Proclaim 7 Elite IPG Model 3662), Proclaim Plus 5 IPG Model 3670, Proclaim Plus 7 IPG Model 3672, Proclaim DRG IPG Model 3664, Infinity 5 IPG Model 6660 и Infinity 7 IPG Model 6662. Depending on the modification, these implants are used to stimulate the spinal cord, the dorsal root ganglion, and for deep brain stimulation.

Proclaim XR 5 IPG Model 3660

The listed devices have a special function that turns off therapy during the patient's magnetic resonance imaging (MRI). Control is carried out via Bluetooth from a smartphone or tablet. However, in some cases, the implants, going into MRI mode, lose the Bluetooth connection, which does not allow them to return to normal operation. As a result, neurostimulation stops, which can cause significant harm to health. Moreover, patients with Parkinson's disease and motor disorders who receive deep brain stimulation are at significant risk of complications and even death during surgery.

The recall program includes more than 155 thousand products from the listed series, which were distributed from November 21, 2015 to June 29, 2023. As of mid-September 2023, 186 incidents related to the use of defective products are known. 73 people were injured, but no deaths were recorded.^[1]

2019: Announcement

In late September 2019, Abbott released a spinal cord stimulant to manage chronic pain, which is expected to last up to 10 years on a single charge.

The Proclaim XR neurostimulation system allows the use of low-energy therapy with short pulses that save battery power. The system was designed to mimic the natural patterns found in the brain and uses soft, short electrical impulses to modify pain signals when transmitted from the spinal cord to the brain. According to company representatives, the protocol for using short pulses allowed to increase the battery life to 10 years. In addition, Proclaim XR can be connected to Apple mobile devices via Bluetooth and regulate therapy accordingly.

Proclaim XR Spinal Cord Stimulator for Chronic Pain Relief That Will Last Up to 10 Years on a Single Charge

Abbott developed this system after receiving the multi-promising results of the study. It turned out that all 24 patients registered in the program of low-energy therapy with short pulses had pain relief when using the battery for less than six hours a day, and in half the effect was achieved at the minimum pulse intensity (less than two hours of battery use per day). The results of this study were presented at several meetings of medical societies and formed the basis of the new development.

Virginia Timothy Deer, President and Executive Director of the Center for Spinal and Nerve Diseases of the State, noted that Proclaim XR is a major achievement in the field of spinal cord stimulation, a system based on evidence-based medicine, using mobile applications and equipped with an updatable one. software The latter means that patients will not need to undergo repeated surgery when new therapeutic options emerge.^[2]

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