Abbott (NYSE: ABT) has recalled more than 155,000 implantable pulse generators (IPGs) due to a Bluetooth connectivity flaw that has left some devices unusable.
The Class I recall — the FDA’s most serious level — covers Proclaim and Infinity IPGs used for three kinds of neurostimulation:
- Spinal cord stimulation: Proclaim XR 5 IPG Model 3660 (previously known as the Proclaim 5 Elite IPG Model 3660), Proclaim XR 7 IPG Model 3662 (previously known as the Proclaim 7 Elite IPG Model 3662), Proclaim Plus 5 IPG Model 3670, and Proclaim Plus 7 IPG Model 3672
- Dorsal root ganglion stimulation: Proclaim DRG IPG Model 3664
- Deep brain stimulation: Infinity 5 IPG Model 6660 and Infinity 7 IPG Model 6662
These devices were distributed in the U.S. from Nov. 21, 2015, to June 29, 2023. The FDA said 186 incidents and 73 injuries have been reported in connection with the issue.
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. 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.
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. 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 surgery
Abbott advised patients to contact their physician before having an MRI to discuss all critical information regarding MRI scans and MRI mode.
An Urgent Medical Device Correction letter from Abbott to surgeons in July offered recommendations to prevent the problem from bricking the implants:
- 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.
- 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. 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 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.
Abbott said in a statement that no devices need to be returned and that physicians can continue to use the Proclaim and Infinity systems.
“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,” the company said. “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 FDA approved Abbott’s Patient Controller smartphone app in 2020.
More details on the recall are available from the FDA.
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