Serena™ Quad CRT-P MRI SureScan™
MEDTRONIC, INC. · Model W4TR02
CRTP W4TR02 SERENA QUAD CRTP MRI US
Intended use: A battery-powered, hermetically-sealed pulse generator, intended to be implanted beneath the skin of the chest in a surgically-created pocket, and used with pacing leads placed in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber) to stimulate the heart to beat at a faster rate when it senses bradycardia and provides cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions to treat symptoms of heart failure (e.g., easy fatigue) and serious heart-rhythm problems [CRT pacemaker (CRT-P)]; it is not intended for defibrillation therapy.
Key tips
- ·Never bypass a radiation interlock to "just get the image" - this is one of the few true zero-tolerance rules in BMET work.
- ·Trend image-quality phantom results over time - drift shows up before an outright failure does.
- ·Portable/mobile units take real physical abuse from transport - check wheel locks and cable strain reliefs more often than fixed units.
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 QC per modality: image-quality phantom test
- ·Tube and detector inspection
- ·Annual state-required radiation safety survey
- ·Vendor-scheduled preventive maintenance
Technical Specs
- Storage Environment Temperature
- 0°F to 131°F
- MRI safety
- MR Conditional
- Sterile
- Yes
- Single use
- Yes
- Prescription use
- Rx only
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Cardiac resynchronization therapy implantable pacemaker
- FDA product classification
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Manufacturer support
- +1(800)633-8766 · Corporate.UDI@medtronic.com
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Radiology / Imaging department
- Emergency Department (portable units)
- Operating Room (C-arms)
- Cath lab
- Bedside ICU (portable X-ray)
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
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