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.