In August 2024, Abbott provided a letter to patients and physicians regarding a system update available to correct the issue with the Liberta RC™ DBS System stimulation turning off at approximately 50-day intervals. This is a follow-up communication to the previous communication from May 2024. Please find the physician and patient communication documents below for further information.

Liberta RC™ DBS System Important Information for Patients - August 8, 2024

Liberta RC™ DBS System Important Information for Physicians - August 8, 2024

In June 2024, Abbott issued an Urgent Medical Device Correction regarding the implantable pulse generator (IPG) battery elective replacement indicator (ERI) for patients with non-rechargeable Proclaim™ SCS Family, Proclaim™ DRG Neurostimulation System and Infinity™ DBS System.  The duration between the IPG reaching ERI threshold and end of service (EOS) may be shorter than indicated in the product labeling. Please find the below physician communication document for further information.

Proclaim™ SCS Family and Proclaim™ DRG Neurostimulation System Important Information for Physicians - June 7, 2024

Infinity™ DBS System Important Information for Physicians - June 7, 2024

In May 2024, Abbott issued an Urgent Medical Device Recall regarding stimulation turning off at approximately 50-day intervals on the Liberta RC™ DBS System. Please find the below physician and patient communication document for further information.

Liberta RC™ DBS System Important Information for Patients - May 24, 2024

Liberta RC™ DBS System Important Information for Physicians - May 24, 2024

Abbott issued an Urgent Medical Device Correction communicating the risk of the inability to exit magnetic resonance imaging (MRI) mode if the Patient Controller has lost the ability to connect or communicate with the IPG while in MRI mode. This applies to the Proclaim™ XR SCS System, Proclaim™ Elite SCS System, Proclaim™ Plus SCS System, Proclaim™ DRG Neurostimulation System and Infinity™ DBS System.

In October 2023, Abbott issued letters to affected SCS and DRG patients and DBS healthcare providers (HCPs). These are subsequent letters to the original healthcare provider letter dated on July 2023.

Please find the communication documents below for further information.

Proclaim™ SCS Family and Proclaim™ DRG Neurostimulation System - MRI Mode Important Information - October 5, 2023

Infinity™ DBS System - MRI Mode Important Information for HCPs - October 5, 2023

Infinity™ DBS System - MRI Mode Important Information for Patients - October 5, 2023

In July 2023, Abbott issued an Urgent Medical Device Correction notice to customers communicating the risk of the inability to exit magnetic resonance imaging (MRI) mode if the Patient Controller has lost the ability to connect or communicate with the IPG while in MRI mode. This applies to the Proclaim™ XR SCS System, Proclaim™ Elite SCS System, Proclaim™ Plus SCS System, Proclaim™ DRG Neurostimulation System and Infinity™ DBS System. Please find the communication document below for further information.

Proclaim™ SCS Family, Proclaim™ DRG Neurostimulation System and Infinity™ DBS System - MRI Mode Important Information - July 21, 2023

On November 11, 2019, Abbott provided an Urgent Medical Device Recall notice to customers communicating that a single lot of Classic Radiofrequency Cannula—Curved (Model C-1005-S) were manufactured with a 10-mm active tip length instead of the labeled 5-mm active tip length. Please find the communication document below for further information.

Classic Radiofrequency Cannula - Curved Important Information - November 11, 2019

On October 14, 2019, Abbott provided an Urgent Medical Device Recall notice to customers communicating that a select number of Radiofrequency Grounding Pads (Model RF-DGP-L) were manufactured with the protective release liner in an incorrect orientation. Please find the communication document below for further information.

Radiofrequency Grounding Pad Important Information – October 14, 2019

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.

St. Jude Medical Infinity™ DBS System 8-Channel Lead Electrode (Model 6170ANS and 6172ANS) – October 29, 2018

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.

St. Jude Medical Infinity™ DBS System 8-Channel Lead Electrode (Model 6170ANS and 6172ANS) – October 11, 2018

On March 14, 2018, Abbott provided an Important Medical Device Advisory to physicians regarding the Proclaim™ DRG Neurostimulation System implantable pulse generator (IPG) (model: 3664).

Important Medical Device Advisory: Proclaim™ DRG Neurostimulation System IPG Impedence Error – March 14, 2018

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 FAMILY AND PROCLAIM™ DRG NEUROSTIMULATION SYSTEM DEVICES

PDF Important Medical Device Advisory: Proclaim™ Elite SCS and Proclaim™ DRG IPG devices – September 12, 2017

INFINITY™ DBS IPG DEVICES

PDF Important Medical Device Advisory: Infinity™ DBS IPG devices – September 12, 2017

ADDITIONAL RESOURCES

PDF ERI Advisory Frequently Asked Questions (53kb)

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).

Important Medical Device Advisory: NM Implantable Pulse Generator (IPG) Inoperable When Exposed to Monopolar Electrosurgery – June 2, 2017

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:

Important Medical Device Correction Update: Eon™ Charging System – July 2014

Important Medical Device Safety Information: Eon™ Charging System – July 2014

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:

Updated Medical Device Information: Eon Mini™ IPG – July 2012

Important Medical Device Information: Eon Mini™ IPG – May 2011

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:

Updated Medical Device Information: Eon™ and Eon Mini™ IPGs – July 2012

Important Medical Device Information: Eon™ and Eon Mini™ IPGs – December 2011

Letter to Patients from St. Jude Medical – July 2012

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

PDF Important Medical Device Information: Eon Mini™ IPG – December 2011