Premature Battery Depletion - SJM ICD and CRT-D

Premature Battery Depletion of St. Jude Medical ICD and CRT-D Devices 

On October 11 2016, the U.S. Food and Drug Administration issued a safety communication alerting health care providers and patients about premature battery depletion in a subset of St. Jude Medical ICD and CRT-D devices. The devices addressed in this communication are the following St. Jude Medical ICD and CRT-D models manufactured before May 2015:

Fortify VR
Fortify ST VR
Fortify Assura VR
Fortify Assura ST VR
Fortify DR
Fortify ST DR
Fortify Assura DR
Fortify Assura ST DR
Unify
Unify Quadra
Unify Assura
Quadra Assura
Quadra Assura MP
Look up a device by serial number to determine if it is affected here .

HRS recommends that physicians contact all of their affected patients to reinforce the FDA's recommendations and schedule office visits to discuss the details of the safety communication. Physicians, patients and their care-givers should determine the best course of action based on individuals' medical history, comorbidities, and clinical conditions.

HRS strongly supports the FDA's recommendation to employ remote monitoring to assist in the early detection of premature battery depletion. This is consistent with the recent HRS Expert Consensus Statement on Remote Interrogation and Monitoring for Cardiovascular Electronic Implantable Devices , which includes a Class I recommendation (level of evidence A) for monitoring all patients.

Educational Activities

Webinar - HRS Roundtable: Managing Risk of Premature and Rapid Battery Depletion- Are you aware of the battery depletion issues which led to an FDA safety communication on the St. Jude Medical ICD and CRT-D devices? HRS released a 70 min webinar discussing how to best managed patients affected by the battery depletion issues of the St. Jude Medical ICD and CRT-D devices. View the webinar

Live Twitter Chat-The Heart Rhythm Society hosted a live webinar and Twitter Chat on October 24, 2016.

Transcript of the Twitter Chat #STJDevice 665.88 kB

Resources

Heart Rhythm Society
HRS Expert Consensus Statement on Remote Interrogation and Monitoring for Cardiovascular Electronic Implantable Devices
Webinar: Remote Interrogation & Monitoring of Cardiovascular Implantable Electronic Devices Remote Monitoring

Remote Monitoring and Interrogation for CEIDs Pocket Guide 840.12 kB

Food and Drug Administration
FDA Safety Communication
Report an Adverse Event: MedWatch

St. Jude Medical
Patient Information and FAQ

St Jude- Dear Dr Letter 102016 479.14 kB St Jude Letter Estimated Performance 102016 42.35 kB