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Health Canada Medical devices

Proclaim and Infinity Implantable Pulse Generators

Issued August 15, 2023
Issue
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. Abbott sent a customer communication on 2023-07-21 to remind health care providers about use of the magnetic resonance imaging (MRI) mode feature on these systems and the associated risks related to inability to exit MRI mode, including the potential need for additional surgery to restore therapy. Recall start date: July 21, 2023
Hazard description
Performance
Product
Product name
Proclaim and Infinity Implantable Pulse Generators
Reference
ID
RA-74120