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St. Jude Medical Fortify Assura User Manual

St. Jude Medical Fortify Assura
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Ellipse™
Fortify Assura™
Tiered-therapy Cardioverter/Defibrillator
Quadra Assura™, Quadra Assura MP™
Unify Assura
Cardiac Resynchronization Device, Tiered-therapy Cardioverter/Defibrillator
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St. Jude Medical Fortify Assura Specifications

General IconGeneral
Device TypeImplantable Cardioverter Defibrillator (ICD)
ModelFortify Assura
ManufacturerSt. Jude Medical (now Abbott)
TherapyDefibrillation, Bradycardia Pacing
Lead CompatibilitySt. Jude Medical/Abbott leads; consult device manual for specific lead compatibility
ProgrammingProgrammable via Merlin@home or Merlin Programmer
Shock EnergyUp to 40J
Pacing ModesVVI, DDD, DDDR
MRI CompatibilityMRI conditional; specific conditions apply, consult device manual and Abbott's MRI guidelines
CommunicationTelemetry (radio frequency) communication with external programmer

Summary

Indications and Usage

Contraindications

Warnings and Precautions

Resuscitation Availability

Ensure external defibrillator and skilled personnel are available for device testing.

Lead System Compatibility

Use only compatible lead systems to ensure proper function and prevent errors.

Shock Prevention During Handling

Disable therapies or program them off during handling to prevent accidental shocks.

Additional Pacemaker Implantation

Ensure compatibility and programming when using an additional pacemaker with the device.

Device Modification and RF Communication

Device Modification

Do not modify the device as it may void operating authority and affect compliance.

Sterilization, Storage and Handling

Follow-up Testing

Implantation and Device Programming

Magnet Usage and Battery Replacement

Do not use magnets over the device; replace device at ERI.

Implantation Depth and Setscrew Caution

Implant generator no deeper than 5 cm; exercise caution with setscrew.

Parameter Programming

Program device parameters using the Merlin PCS on-screen help.

Pulse Generator Explant and Disposal

Environmental and Medical Therapy Hazards

Hospital and Medical Environments

Potential Adverse Events

Arrhythmias, Embolism, and Allergic Reactions

Potential adverse events including arrhythmias, air embolism, and allergic reactions.

Physical Complications

Potential physical complications include bleeding, erosion, infection, and myocardial damage.

Clinician Use Information

Maintaining Device Effectiveness

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