The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices can result in serious injury or death.
- Product name and model number:
- Distribution date: November 21, 2015 to June 29, 2023
- Devices recalled in the US: 155,028
- Start date by company: July 18, 2023
Using the device
The Abbott Proclaim Neurostimulation System delivers low-intensity electrical impulses to neural structures.
Proclaim XR and Proclaim Plus implantable pulse generators (IPGs) are used for spinal cord stimulation (SCS). Proclaim DRG IPG is used for dorsal root ganglion (DRG) stimulation. Infinity IPG is used for deep brain stimulation (DBS).
The device has an option to disable treatment delivery when a patient is undergoing magnetic resonance imaging (MRI). A patient controller (PC) device, i.e. an iPhone or iPod with a PC application (app) installed, connects wirelessly to the patient’s girlfriend IPG via Bluetooth. The PC device is used to put the patient’s IPG into her MRI mode, which disables treatment delivery. Once the MRI procedure is complete, her MRI mode on her IPG is deactivated using the PC device, allowing treatment to resume.
Reason for recall
Abbott is recalling Proclaim and Infinity IPGs due to complaints from patients who were unable to exit MRI mode. While in MRI mode, the patient controller (iPhone/iPod) may not be able to connect or communicate with her IPG. Examples of situations where this can occur include when the PC device’s iOS operating system is updated, when the PC app is updated or removed, or when his IPG is removed from the list of available Bluetooth devices on the PC device. There are times, etc. A clinician programmer must pair with the IPG for initial programming. If available, the clinician programmer that was previously paired with the patient’s IPG can be used to exit MRI mode. There is no alternative option to exit MRI mode if there is no previously paired clinician programmer available or if the clinician programmer loses her Bluetooth connection to her IPG.
Using an affected IPG may require surgery to remove the device and replace it with a new one.
There were 186 reported incidents and 73 injuries. There are no reports of deaths.
Who may be affected?
- Anyone receiving neurostimulation from the Proclaim XR SCS System, Proclaim Plus SCS System, Proclaim DRG Neurostimulation System, or Infinity DBS System.
- Subpopulations for these devices may include patients with Parkinson’s disease and movement disorder patients receiving DBS treatment. They have high morbidity and mortality after each surgery, and therefore unnecessary anesthetic events and surgeries increase the risk.
- Healthcare professionals providing care that includes the Proclaim XR SCS System, Proclaim Plus SCS System, Proclaim DRG Neurostimulation System, and Infinity DBS System. Referring physicians include, but are not limited to, neurosurgeons, neurologists, primary care physicians, pain specialists, etc. .) Someone who is likely to monitor the patient on a regular basis.
what will you do
On July 18, 2023, Abbott sent an Emergency Medical Device Correction Letter to all affected transplant surgeons.
The letter recommends that doctors do the following to reduce the risk of loss:
Treatment and need for IPG replacement surgery:
- For patient controllers, Advise patients not to remove the paired Bluetooth connection between the IPG and patient controller and to not modify, damage, or lose the patient controller while the IPG is in MRI mode.
- For patient controllers before entering MRI mode: Ensure patients have upgraded their patient controllers to the latest version “Patient Controller NR-US” Applications from the Apple App Store. This version of the application provides instructions to the user not to remove the IPG pairing when the system is in his MRI mode.
- For clinician programmers, Preserve paired Bluetooth connectivity between IPG and clinician programmer by avoiding pairing deletion and disabling automatic iOS software upgrades from iOS settings.
For questions regarding this issue, or to report a patient who is unable to exit MRI mode, please contact your local Abbott representative or Abbott Technical Support at 1-800-727-7846 (Option 3).
Complete list of affected devices
A complete list of affected devices is available on the Medical Device Recall Database.
How do I report an issue?
Healthcare professionals and consumers can report side effects or quality problems they experience using these devices to the FDA’s Safety Information and Adverse Event Reporting Program using an online form, regular mail, or fax. You can report it to MedWatch.