- Abbott’s recall of its Proclaim and Infinity neurostimulation systems was categorized by the Food and Drug Administration as a Class I recall.
- Abbott contacted customers in July after receiving complaints from patients who were unable to exit the devices’ MRI mode, a status that disables the delivery of therapy while an individual undergoes magnetic resonance imaging. An additional surgery may be needed to restore therapy.
- To reduce the risk of therapy loss, which has been implicated in 73 injuries, Abbott is advising patients and healthcare professionals to maintain the paired Bluetooth connection.
The affected devices provide stimulation of the spinal cord, dorsal root ganglion and deep brain to treat conditions including chronic pain. Abbott has designed the implants so they are safe to use during MRI, provided the devices are put into a special mode that turns stimulation off. However, some patients have found that while they can stop therapy, they cannot then restart their implants.
The problem may affect 155,028 devices distributed in the U.S. from late 2015 to June 2023.
A Bluetooth-paired iPhone or iPod is used as the patient controller device to put the pulse generator in and out of MRI mode. If the user deletes the Bluetooth pairing, loses or disables the controller or upgrades the iOS software while in MRI mode, it cannot connect with the implant to restore therapy.
When that happens, only a previously paired clinician programmer can restore therapy. If no previously paired device is available, the patient needs to undergo surgery to replace the implantable pulse generator and restore therapy.
Abbott has received 186 reports about the problem and 73 notices of injuries. No patients have died. Globally, the occurrence rate is 0.06%, and the additional surgery rate is 0.03%, Abbott said in its notice to customers.
Users of the devices can avoid the problem by taking certain precautions when entering MRI mode. Abbott is advising patients not to delete the paired Bluetooth connection while in MRI mode, and to ensure that they have the latest version of the app before entering the mode. The latest app provides instructions for not deleting the Bluetooth connection. Clinician programmers should maintain connections as a backup.