Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electro

FDA device recall Z-2510-2023 · posted 2023-09-11 · Open, Classified

Recall details

Recalling firm

Abbott Medical

Reason for recall

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LGW

Quantity affected

5,932 devices (US-4,464; OUS-1,468)

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

Date initiated

2023-07-18

Date posted

2023-09-11

Location

Plano, TX