Unify Quadra™
ST. JUDE MEDICAL, INC. · Model CD3249-40
Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV
Intended use: An implantable, battery-powered device consisting of a hermetically-sealed pacing pulse generator and an integrated defibrillation pulse generator with leads in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber). In addition to conventional pacing and defibrillation functions, the device is intended to provide cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions for more effective blood pumping to treat symptoms of heart failure (e.g., shortness of breath, easy fatigue) and serious heart-rhythm problems [CRT defibrillator (CRT-D)].
Key tips
- ·Never skip the daily/shift ready-check - a defibrillator found dead during a code is a real, repeated root-cause finding.
- ·Pads and batteries have real expiration dates - check them on every PM, not just at annual service.
- ·Verify energy-delivery accuracy with a real defibrillator analyzer, not just a self-test pass.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Daily/shift visual and self-test check (AAMI EQ56 daily-ready standard)
- ·Battery and pad expiration-date tracking
- ·Energy-delivery accuracy test against a defibrillator analyzer
- ·Paddle/cable continuity check
- ·Annual full PM
Technical Specs
- Handling Environment Temperature
- -20°C to 60°C
- Storage Environment Temperature
- 50°F to 113°F
- Total Volume
- 40 Milliliter
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- Yes
- Single use
- Yes
- Prescription use
- Rx only
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Cardiac resynchronization therapy implantable defibrillator
- FDA product classification
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Manufacturer support
- +1(855)478-5833 · customerservice@sjm.com
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Crash carts (every unit)
- Emergency Department
- ICU
- OR
- Code-blue response areas
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
- RECALL
St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.
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