FDA identifies Abbott’s Proclaim and Infinity IPGs recall as Class I

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled product

• Product Names and Model Numbers:
  • 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
• Distribution Dates: November 21, 2015, to June 29, 2023
• Devices Recalled in the U.S.: 155,028
• Date Initiated by Firm: July 18, 2023

Device use
The Abbott Proclaim neurostimulation systems delivers low-intensity electrical impulses to nerve structures.

The Proclaim XR and Proclaim Plus implantable pulse generators (IPGs) are used for Spinal Cord Stimulation (SCS). The Proclaim DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity IPGs are used for Deep Brain Stimulation (DBS).

The device has the option to disable delivery of therapy when a patient receives magnetic resonance imaging (MRI). 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 PC device is used to place a patient’s IPG in MRI mode, which disables the delivery of therapy. When the MRI procedure is complete, the PC device is then used to deactivate the IPG’s MRI mode and allow therapy to resume.

Reason for recall
Abbott is recalling its Proclaim and Infinity IPGs due to complaints from patients who are unable to exit MRI mode. The Patient Controller (iPhone/iPod) may lose the ability to connect or communicate with its IPG while in MRI mode. Example situations where this has occurred include when the PC device’s iOS operating system was updated, the PC app was updated or deleted, and when the IPG was deleted from the list of available Bluetooth devices on the PC device. A Clinician Programmer is required to be paired to the IPG for initial programming. When available, a Clinician Programmer previously paired with the patient’s IPG can be used to exit MRI mode. If there is no previously paired Clinician Programmer available, or if the Clinician Programmer lost its Bluetooth connection to the IPG, then there is no alternative option to exit MRI mode.

The use of the affected IPGs may require surgery to remove the device and replace it with a new device.

There have been 186 reported incidents and 73 reported injuries. There have been no reports of death.

Who may be affected

• People that receive 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 persons with Parkinson’s disease and movement disorder patients receiving DBS treatment. They have higher morbidity and mortality with every surgery, thus otherwise unneeded anesthesia events and surgeries pose an increased hazard.
• Health care personnel providing care that includes the Proclaim XR SCS System, Proclaim Plus SCS System, Proclaim DRG Neurostimulation System and Infinity DBS Systems, including but not limited to referring physicians (for example: neurosurgeons, neurologists, primary care physicians, pain specialists, etc.) who are more likely to monitor patients on a regular basis.

What to do
On July 18, 2023, Abbott sent all affected implanting surgeons an Urgent Medical Device Correction letter.

The letter recommended that physicians do the following to reduce risk of loss of therapy and the need for IPG replacement surgery:

• 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.

MB Bureau