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![]() Reason for RecallĪbbott is recalling its Proclaim and Infinity IPGs due to complaints from patients who are unable to exit MRI mode. When the MRI procedure is complete, the PC device is then used to deactivate the IPG’s MRI mode and allow therapy to resume. The PC device is used to place a patient’s IPG in MRI mode, which disables the delivery of therapy. The Patient Controller (PC) device, an iPhone or iPod installed with the PC application (app), connects to the patient’s IPG wirelessly via Bluetooth. The device has the option to disable delivery of therapy when a patient receives magnetic resonance imaging (MRI). The Infinity IPGs are used for Deep Brain Stimulation (DBS). The Proclaim DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Proclaim XR and Proclaim Plus implantable pulse generators (IPGs) are used for Spinal Cord Stimulation (SCS). The Abbott Proclaim neurostimulation systems delivers low-intensity electrical impulses to nerve structures. Distribution Dates: November 21, 2015, to June 29, 2023.Proclaim XR 7 IPG Model 3662 (Previously known as the ‘Proclaim 7 Elite IPG Model 3662’).Proclaim XR 5 IPG Model 3660 (previously known as the ‘Proclaim 5 Elite IPG Model 3660’).Use of these devices may cause serious injuries or death. ![]() “We apologize for any inconvenience this may cause you and your patients, and we appreciate your support in ensuring patient safety and customer satisfaction.The FDA has identified this as a Class I recall, the most serious type of recall. “Abbott is committed to providing the highest quality products and support,” the company’s letter concluded. Meanwhile, they should be careful not to alter their own connections with their patients’ IPGs-via the Clinician Programmer app-by maintaining Bluetooth pairings and disabling any automatic software updates that may take place while a device is in MRI mode. They should also ensure that patients have updated the app’s software to its latest version before entering the scan-safe mode. The devicemaker recommended that physicians also remind their patients not to break the Bluetooth connection, nor to alter, damage or lose the Patient Controller while the device is in MRI mode. Since receiving the complaints, Abbott has not only updated the devices’ instructions for use but also added a note to the Patient Controller app’s screen while it’s in MRI mode to remind patients not to delete the Bluetooth pairing between the app and implant. However, it noted in the letter that the issue’s incidence rate was hovering around 0.06% of all of the devices distributed around the world, about half of which required additional surgeries to correct. In those cases, surgery will be needed to remove the old IPG and implant one that can be connected anew to a Patient Controller.Ībbott didn’t disclose the exact number of complaints it’s received related to the issue, nor whether any associated injuries or patient deaths have occurred. If a user isn’t able to access the Patient Controller that was previously paired with their IPG, they won’t be able to exit MRI mode, therefore preventing their neuromodulation therapy from resuming. The company attributed the lost connections to instances where a user deleted the Bluetooth pairing between the app and IPG, lost or disabled the app or upgraded the iOS software on the Apple device while the IPG was in MRI mode. ![]() These incidents occurred when the implantable pulse generator (IPG) had lost communication with the Patient Controller app, which is installed on either a user’s own Apple device or one provided by Abbott. According to a letter (PDF) Abbott sent to healthcare provider customers in July, some users submitted complaints describing how they’d been unable to resume neuromodulation therapy after a stint in MRI mode.
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