Proclaim recallZ-2508-2023 · Abbott Medical · initiated Jul 18, 2023

Why it was recalled

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

FDA root cause category: Under Investigation by firm

What the company is doing

On 07/20/2023, the firm will send an "URGENT MEDICAL DEVICE CORRECTION" Letter via mail with delivery tracking to customers informing them, Abbott has received complaints from patients who are unable to exit MRI mode, as their Patient Controller has lost the ability to connect or communicate with their IPG while in MRI mode. Situations where this has occurred include where the user deleted the Bluetooth pairing, lost or disabled their Patient Controller, or upgraded the iOS! software on their Patient Controller while in MRI mode. Next Steps for Customers: Per Abbott's Instructions for Use, patients are advised to contact their physician before having an MRI to discuss all critical information regarding MRI scans and MRI mode. In alignment with the Clinician Programmer and Patient Controller Instructions for Use, Abbott recommends physicians do the following: " 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. " For questions about this issue or to report patients who are unable to exit MRI mode, please contact your local Abbott representative or Abbott Technical Support at 1-800-727-7846 (option 3) for assistance.

Recall details

Recall number

Z-2508-2023

Status

Open, Classified

Initiated by the company

Jul 18, 2023

Posted by the FDA

Sep 11, 2023

Recalling firm

Abbott Medical

Quantity

387 devices (US only)

Product code

LGW

FDA submissions

P010032, P010032S096, P010032S151

Distribution

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Korean, Kuwait, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom.

Product description

Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Proclaim™ 3672

  St. Jude Medical, Inc. · Stimulator, spinal-cord, totally implanted for pain relief
  2 recalls121 reports

Product lines

• ProclaimSt. Jude Medical, Inc. · 12 models · 35,038 reports · 17 recalls

Other devices under the same FDA submission

109 devices cleared under P010032, P010032S096, P010032S151 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• Octrode™ 3186

  St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  30 deaths32,096 reports
• Proclaim™ 3660

  St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  2 recalls25 deaths13,336 reports
• Proclaim™ 5 Elite

  St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  1 recall10 deaths9,661 reports
• Proclaim™ 7 Elite

  St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  1 recall12 deaths7,299 reports
• Penta™ 3228

  St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  11 deaths5,201 reports
• Eon Mini™ 3788

  St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  1 death4,666 reports
• Prodigy MRI™ 3772

  St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  2 deaths3,162 reports
• Octrode™ 3189

  St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  8 deaths2,238 reports
• Protégé MRI™ 3771

  St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  1,997 reports
• Eterna™ 32400

  St. Jude Medical, Inc. · Stimulator, spinal-cord, totally implanted for pain relief
  1 recall5 deaths1,547 reports
• Octrode® 3186

  Advanced Neuromodulation Systems, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  2 deaths1,455 reports
• Swift-Lock™ 1192

  St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  1,400 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 92688).

• Z-2505-2023 · Open, Classified
  Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electr…
• Z-2506-2023 · Open, Classified
  Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse generator (IPG) is an electronic device …
• Z-2507-2023 · Open, Classified
  Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more ext…
• Z-2509-2023 · Open, Classified
  Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extens…
• Z-2510-2023 · Open, Classified
  Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensio…
• Z-2511-2023 · Open, Classified
  Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensio…