Safety Alerts

Medical device manufacturer, Abbott Medical, has issued a medical device safety alert concerning its Proclaim, Infinity Implantable Pulse Generators and Clinician Programmer Application and Patient Controller Application [Model Number: 3660, 3662, 3664, 3670, 3672, 6660, 6662, 3874, 3875] [HKMD No.: 210488, 230053].

The manufacturer has received complaints from patients who are unable to exit magnetic resonance imaging (MRI) mode, as their Patient Controller has lost the ability to connect or communicate with their implantable pulse generator (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. If there is no previously paired Clinician Programmer available, this will result in the inability to exit MRI mode. If additional troubleshooting steps are unsuccessful, the implanted device would be unable to exit MRI mode and additional surgery would be required.

For further information, please visit
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA):
https://mhra-gov.filecamp.com/s/d/BRQrbpbDt4QQIdHa
https://mhra-gov.filecamp.com/s/d/t4jxJjVitpWH54Ow

國家藥品監督管理局 (NMPA): https://www.nmpa.gov.cn/xxgk/chpzhh/ylqxzhh/ylqxzhhzj/20230804084639190.html
https://www.nmpa.gov.cn/xxgk/chpzhh/ylqxzhh/ylqxzhhzj/20230919151032113.html

Health Canada: https://recalls-rappels.canada.ca/en/alert-recall/proclaim-and-infinity-implantable-pulse-generators

The United States Food and Drug Administration (FDA):
https://www.fda.gov/medical-devices/medical-device-recalls/abbott-medical-recalls-proclaim-and-infinity-ipgs-inability-exit-magnetic-resonance-imaging-mri-mode
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=92688

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 31 Jul 2023
Updated on 13 Dec 2023