Proclaim XR and Proclaim Plus Implantable Pulse Generator Recall Follows Dozens of Reports Involving MRI Injuries
Abbott has issued a recall of more than 155,000 implantable pulse generator devices, which are used to provide brain and spinal cord stimulation to individuals with Parkinson’s disease and other movement disorders, following dozens of reported injuries that occurred when the implants were unable to be reactivated following an MRI procedure.
The U.S. Food and Drug Administration (FDA) announced the implantable pulse generator recall on September 13, indicating the manufacturer is aware of at least 186 incidents involving failure of therapy delivery, which has resulted in at least 73 injuries.
The implantable systems provide work by delivering low electrical impulses to nerve structures. The devices can be placed in MRI (magnetic resonance imaging) mode, which disables therapy delivery while patients are undergoing an exam. The MRI mode is supposed to be deactivated wirelessly using an iPhone or iPod application after the MRI scan is complete, so to resume therapy.
However, according to the recall notice, the manufacturer has received complaints indicating the connected iPhone or iPod lost communication with the implanted device, which can prevent it from exiting MRI mode and resuming therapy delivery. This appears to occur after a connected iPhone or iPod received an update, after the application was updated or deleted, and after the device was removed from the list of paired devices.
Federal regulators warn that patients with implantable devices that fail to deliver therapy may require surgery to remove and replace the device.
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Abbott Implantable Pulse Generator Recall
The recall impacts approximately 155,028 Abbott implantable pulse generators distributed from November 15, 2015 until June 29, 2023. It includes the following models:
- 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
- Proclaim Plus 7 IPG Model 3672
- Proclaim DRG IPG Model 3664
- Infinity 5 IPG Model 6660
- Infinity 7 IPG Model 6662
Abbott issued an urgent medical device correction letter to customers, notifying them of the risk of therapy loss and potential need for a replacement surgery. The manufacturer recommended patients use the latest application software update before using MRI mode, and maintain the connection between their phone and device while using MRI mode.
For more information, consumers may contact their local Abbott representative, or call Abbott Technical Support at 1-800-727-7846 and select option 3 for assistance. The FDA is also encouraging consumers to report any adverse side effects or events to the MedWatch Adverse Event Reporting program using the online reporting form.
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