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On October 29, 2018, Abbott provided an Urgent Medical Device Recall notice to customers communicating that a select number of 8-Channel Leads for the St. Jude Medical Infinity™ DBS System may contain an electrode that was not manufactured to our material specification which causes it to appear lighter under radiography. Please find the below physician communication document with patient management recommendations for further information.
On October 11, 2018, Abbott provided an Urgent Medical Device Recall notice to customers communicating that a select number of 8-Channel Leads for the St. Jude Medical Infinity™ DBS System may contain an electrode that was not manufactured to our material specification which causes it to appear lighter under radiography. Please find the below hospital communication documents for further information.
On March 14, 2018, Abbott provided an Important Medical Device Advisory to physicians regarding the Proclaim™ DRG (Dorsal Root Ganglion) Implantable Pulse Generator (IPG) Neurostimulator Systems (model: 3664).
On September 12, 2017, Abbott provided an Important Medical Device Advisory to physicians regarding the Proclaim™ SCS IPG devices, Proclaim™ DRG IPG devices and Infinity™ Deep Brain Stimulation (DBS) IPG devices in which a software calculation error has caused the elective replacement indicator (ERI) in some devices has triggered earlier than intended.
Read the Important Medical Device Advisory documents and FAQ documents for details regarding risk and patient management recommendations:
Proclaim™ SCS and Proclaim™ DRG IPG devices
Infinity™ Deep Brain Stimulation (DBS) IPG devices
Additional Resources
On June 2, 2017, St. Jude Medical provided an Important Medical Device Advisory to physicians regarding the St. Jude Medical implantable pulse generator (IPG) devices implanted before June 2, 2017 for Proclaim™ Elite SCS IPG (models: 3660 and 3662) and Infinity™ DBS IPG (models: 6660, 6661, 6662 and 6663).
On July 21, 2014, St. Jude Medical provided an update letter to physicians regarding Eon™ implantable pulse generators. This is an update to the previous voluntary device correction letter, dated December 19, 2011. See both physician letters and a patient safety information letter below:
On July 26, 2012, St. Jude Medical provided an update letter to physicians regarding the Eon Mini™ implantable pulse generator. This is an update to the previous voluntary recall notification letter, dated May 24, 2011. See both letters below:
On July 21, 2012, St. Jude Medical provided an update letter to physicians regarding Eon™ and Eon Mini™ implantable pulse generators. This is an update to the previous voluntary device correction letter, dated December 19, 2011. See both physician letters and a patient safety information letter below:
On December 19, 2011, St. Jude Medical provided a letter to physicians regarding the Eon Mini™ implantable pulse generator.
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