Abbott
Published on Jun 01, 2017
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PRESENTATION OUTLINE
Abbott
St. Jude Medical ICD & CRT-D Devices
800,000
U.S. Citizens have ICD's or CRT-D's
10,000 different types of ICD's are implanted every month. ICD means Implantable Cardioverter Defibrillator or the Cardiac Resynchronization Therapy Defibrillator (CRT-D)
An ICD is implanted to help treat tachycardia-a fast heart rate-or when there's risk of Sudden Cardiac Arrest.
It is designed to deliver two levels of electrical energy: a low energy shock that can convert a beating heart that is in an abnormal rhythm back to a normal heartbeat, and a high energy shock that is delivered only if the arrhythmia is so severe that the heart is only quivering instead of beating.
It sends an electrical shock to convert the fast rhythm to a normal rhythm.
What does it do and what types are available.
Pacemakers are most commonly used in patients whose heartbeat slows to an unhealthy low rate.
ICDs are used in specific patients who are at risk for potentially fatal ventricular arrhythmias (an abnormal rhythm from the lower heart chambers, which can cause the heart to pump less effectively).
A CRT device sends small electrical impulses to both lower chambers of the heart to help them beat together in a more synchronized pattern
There may be other reasons why your doctor advises placement of a pacemaker or ICD.
Pacemakers are most commonly used in patients whose heartbeat slows to an unhealthy low rate.
ICDs are used in specific patients who are at risk for potentially fatal ventricular arrhythmias (an abnormal rhythm from the lower heart chambers, which can cause the heart to pump less effectively).
A CRT device sends small electrical impulses to both lower chambers of the heart to help them beat together in a more synchronized pattern
There may be other reasons why your doctor advises placement of a pacemaker or ICD.
Symptoms of Arrythmias
- Weakness/Fatigue
- Palpitations
- Low Blood Pressure
- Dizziness
- Fainting
Components of the device
- Pulse generator,sealed lithium battery,electronic circuitry package.
- One or more wires (leads).
- Electrodes found on leads.
It has a generator, one or more leads, and an electrode for each lead. These components work very much like a pacemaker.
An implantable cardioverter defibrillator (ICD) looks very similar to a pacemaker, except that it is slightly larger
An implantable cardioverter defibrillator (ICD) looks very similar to a pacemaker, except that it is slightly larger
Types of Pacemakers, ICDs & CRT-Ds
- Temporary
- Implanted traditional cardiac pacemaker with lead wire
- Implanted miniature leadless pacemakers
Most cardiac pacemaker systems generally include a subcutaneous pulse generator placed in the chest wall and transvenous pacing leads affixed to the heart tissue.
ICD related Complications
- Infection at implant site
- Lead issues
- Device Malfunction
- Inappropriate shocks
- End of battery life
Infections might occur after the surgery however these are rare.
Lead-related complications include perforation, lead displacement, lead fracture, and insulation defects.
The majority of ICD generator-related complications consisted of prophylactic generator replacements due to manufacturer recalls. These would require reoperation and additional hospitalization.
95.7 percent of re-implantation surgery occurred due to end of battery life.
Lead-related complications include perforation, lead displacement, lead fracture, and insulation defects.
The majority of ICD generator-related complications consisted of prophylactic generator replacements due to manufacturer recalls. These would require reoperation and additional hospitalization.
95.7 percent of re-implantation surgery occurred due to end of battery life.
$7,251-$18,477
Per Hospital Stay
Patients who experienced complications on average stayed 3.4 days longer.
Re-implantation-related infections cost more per stay and stayed an extra 9.6 days on average.
Re-implantation-related infections cost more per stay and stayed an extra 9.6 days on average.
2016 the FDA identifies St. Jude ICD's as a Class 1 recall the most serious type.
The FDA inspection revealed:
Reports of rapid battery failure caused by deposits of lithium (known as “lithium clusters”), forming within the battery, and causing a short circuit.
Reports of rapid battery failure caused by deposits of lithium (known as “lithium clusters”), forming within the battery, and causing a short circuit.
Battery Failure
- Can occur in 24 hours after alert sounds.
- Patients do not have the normal 3 mo. time for device replacement.
If the battery runs out, the defibrillator will be unable to deliver life-saving pacing or shocks, which could lead to patient death.
•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
These are the St. Jude Medical ICD and CRT-D models manufactured before May 2015 have been recalled.
The device maker, in a letter to doctors, said potential battery depletion could occur among an estimated 398,740 company implantable cardioverter defibrillators worldwide.
The device maker, in a letter to doctors, said potential battery depletion could occur among an estimated 398,740 company implantable cardioverter defibrillators worldwide.
Photo by eflon
