![]() For the Clinician Programmer, 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.Ībbott said in a statement that no devices need to be returned and that physicians can continue to use the Proclaim and Infinity systems. ![]() This version of the application provides instructions for the user not to delete the IPG pairing while the system is in MRI mode. For the Patient Controller prior to entering MRI mode, ensure patients have upgraded their Patient Controller to the latest “Patient Controller NR – US” application from the Apple App Store.For the Patient Controller, advise the patient 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.However, patients with Parkinson’s disease and movement disorders who are receiving DBS treatment, for example, are at greater risk of complications or death during surgeryĪbbott advised patients to contact their physician before having an MRI to discuss all critical information regarding MRI scans and MRI mode.Īn Urgent Medical Device Correction letter from Abbott to surgeons in July offered recommendations to prevent the problem from bricking the implants: When that happens, and there is no previously paired Clinician Programmer able to communicate with the IPG, the only option left is to surgically remove the device and replace it with another. But in some cases, the iPhone or iPod used to communicate with the IPGs via Bluetooth may lose the connection while in MRI mode and remain disabled, leaving the device permanently deactivated. The Abbott IPGs deliver low-intensity electrical impulses to nerve structures and have a feature that disables therapy while a patient undergoes a magnetic resonance imaging (MRI) scan. The FDA said 186 incidents and 73 injuries have been reported in connection with the issue. These devices were distributed in the U.S. Deep brain stimulation: Infinity 5 IPG Model 6660 and Infinity 7 IPG Model 6662.Dorsal root ganglion stimulation: Proclaim DRG IPG Model 3664. ![]()
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