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Abbott is committed to presenting information with accuracy and integrity. As part of our effort to provide the most reliable and safe medical products, we will occasionally publish notices here if we have important information to share. If you have any questions or concerns, please contact your Abbott representative or Abbott Customer Service at 1-866-240-6741.

St. Jude Medical Infinity™ DBS 8
Channel Lead Important Information
29 October 2018

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.

PROCLAIM™ DRG IPG IMPEDANCE ERROR
MARCH 2018

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).

PROCLAIM™ SCS, PROCLAIM™ DRG AND INFINITY™ DBS IPG DEVICES ELECTIVE REPLACEMENT INDICATOR (ERI) IMPORTANT INFORMATION
SEPTEMBER 2017

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

PROCLAIM™ ELITE SCS AND INFINITY™ DBS IMPLANTABLE PULSE GENERATORS (IPG) SURGERY MODE IMPORTANT INFORMATION
JUNE 2017

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).

UPDATE TO EON™ IPG–CHARGING SYSTEM MEDICAL DEVICE CORRECTION
JULY 2014

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:

UPDATE TO EON MINI™ IPG–INNER BATTERY ISSUE MEDICAL DEVICE RECALL/ADVISORY
JULY 2012

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:

UPDATE TO EON™ AND EON MINI™ IPG–CHARGING SYSTEM MEDICAL DEVICE CORRECTION
JULY 2012

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:

EON MINI™ IPG–PREMATURE BATTERY DEPLETION IMPORTANT MEDICAL DEVICE VOLUNTARY RECALL
DECEMBER 2012

On December 19, 2011, St. Jude Medical provided a letter to physicians regarding the Eon Mini™ implantable pulse generator.

SJM-NWEB-0718-0147

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