SelectSecure™ MRI SureScan™
MEDTRONIC, INC. · Model 383069
LEAD 383069 SELECTSECURE US MRI
Intended use: An implantable wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may transmit intrinsic electrical activity from the heart back to the pulse generator. The electrode end is normally placed through a vein to contact the endocardium where it is fixed, or to penetrate the myocardium of the interventricular septum adjacent to the HIS-Purkinje system; the other end is connected to the pulse generator. It may be impregnated with a steroid intended to reduce inflammation.
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
- 77°F to 77°F
- Handling Environment Temperature
- 59°F to 86°F
- Length
- 69.0 Centimeter
- MRI safety
- MR Conditional
- Sterile
- Yes
- Single use
- Yes
- Prescription use
- Rx only
- FDA distribution status
- Not in Commercial Distribution
- Device type (GMDN)
- Endocardial/interventricular septal pacing lead
- FDA product classification
- permanent pacemaker Electrode; Permanent defibrillator electrodes; Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- 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
Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.
- RECALL
During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some batteries were therefore retested and passed.
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