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Abbott Laboratories (NYSE:ABT) has received reports indicating the loss of Bluetooth® connectivity between Abbott’s implantable Proclaim™ and Infinity™ systems and its paired patient controller after a patient has undergone an MRI. Based on these occurrences, Abbott previously updated the patient controller Instructions for Use (IFU) and patient controller application MRI-mode screen on smartphones reminding the patient to not delete the paired Bluetooth connection between their Implantable Pulse Generator (IPG) and the patient controller. Abbott has distributed a physician communication to reinforce the importance of following the steps regarding MRI scans outlined in the IFU.
The company has communicated this action to physicians and regulatory bodies. No products need to be returned to the company or replaced.
Importantly, physicians can continue to use the Proclaim and Infinity systems.
There have been 186 reported incidents and 73 reported injuries. There have been no reports of death. Read more here: FDA source
***After publishing this press release we received a message by Gita Amar representing Abbott on this issue. She stated “The company has communicated this action to physicians and regulatory bodies. No products need to be returned to the company or replaced.” in her email. For further comments on this issue please email: [email protected]
