Abbott Recalls Proclaim and Infinity IPGs for Inability to Exit MRI Mode

The U.S. Food and Drug Administration (FDA) has identified Abbott’s July 18 recall of its Proclaim and Infinity implantable pulse generators (IPGs) as Class I.
 
Abbott’s Proclaim neurostimulation systems deliver low-intensity electrical impulses to nerve structures. The Proclaim XR and Proclaim Plus implantable pulse generators (IPGs) are used for spinal cord stimulation (SCS). The Proclaim DRG IPG is used for dorsal root ganglion (DRG) stimulation. The Infinity IPGs are used for deep brain stimulation (DBS).
 
The devices have the option to disable therapy delivery when a patient receives MRI. The patient controller device, an iPhone or iPod installed with the PC app, connects to the patient’s IPG wirelessly via Bluetooth. The patient controller is used to place a patient’s IPG in MRI mode, disabling therapy delivery. When the MRI is complete, the controller is used to deactivate the IPG’s MRI mode and allow therapy to resume.
 
The Proclaim and Infinity IPGs were recalled because of patient complaints of being unable to exit MRI mode. Abbott said the patient controller (iPhone/iPad) can lose the ability to connect or communicate with its IPG while in MRI mode. Example situations include when the PC device’s iOS system was updated, the PC app was updated or deleted, and when the IPG was deleted from the list of available Bluetooth devices on the PC.
 
A clinician programmer must be paired to the IPG for initial programming, and when available, a clinician programmer previously paired with the patient’s IPG can be used to leave MRI mode. If there’s no such clinician programmer available, or if it lost its Bluetooth connection to the IPG, there’s no alternative option to exit MRI mode, Abbott advised.
 
Using the affected IPGs could require surgery to remove and replace the device. There have thus far been 186 reported incidents, 73 reported injuries, and no reports of death.
 
Abbott told implanting surgeons not to delete the paired Bluetooth connection between their IPG and the patient controller and not to alter, damage, or lose their patient controller while the IPG is in MRI mode. The company also advised them to ensure patients have upgraded their patient controller to the latest “Patient Controller NR - US” application from the Apple App Store.
 
For the Clinician Programmer, they were advised to maintain the paired Bluetooth connection between the IPG and the clinician programmer by avoiding deleting the pairing and disabling automatic iOS software upgrades from the iOS settings.

An Abbott spokesperson responded to ODT to offer additional background:

“Abbott has received reports indicating the loss of Bluetooth connectivity between Abbott’s implantable Proclaim and Infinity systems and its paired patient controller after a patient has undergone an MRI. Based on these occurrences, Abbott previously updated the patient controller Instructions for Use (IFU) and patient controller application MRI-mode screen on smartphones reminding the patient to not delete the paired Bluetooth connection between their Implantable Pulse Generator (IPG) and the patient controller. Abbott has distributed a physician communication to reinforce the importance of following the steps regarding MRI scans outlined in the IFU. 
 
“The company has communicated this action to physicians and regulatory bodies. No products need to be returned to the company or replaced.”
 
“Importantly, physicians can continue to use the Proclaim and Infinity systems.”