STIMULATOR 37021 EXTERNAL,US MARKET
MEDTRONIC, INC. · Model 37021
STIMULATOR 37021 EXTERNAL,US MARKET
Intended use: An assembly of devices that applies an electrical stimulus to all or part of the spinal cord to relieve pain (analgesia). It includes an implanted lead/electrode system located in the epidural space of the spinal cord attached to either an implanted passive electronic circuit into which signals and/or energy is inductively coupled from outside the body, or to a totally implantable self-contained system that carries its own energy source and has no inherent dependence upon external devices. It is used to treat acute and/or chronic intractable pain, where the use of drug therapy is undesirable or no longer effective.
Key tips
- ·When no category-specific guidance fits, default to the manufacturer's own service manual and the general troubleshooting method in the Engineer's Guide.
- ·Run an incoming and annual electrical safety test regardless of how niche the device is.
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.
- ·Follow the manufacturer's PM schedule
- ·Perform incoming and annual electrical safety testing per facility biomedical program
Technical Specs
- Storage Environment Temperature
- -40°F to 149°F
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- No
- Prescription use
- Rx only
- FDA distribution status
- Not in Commercial Distribution
- Device type (GMDN)
- Analgesic spinal cord electrical stimulation system
- FDA product classification
- STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
- 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.
- Varies by device - check the unit's own manual for facility placement guidance
Documents & Manuals
No documents available for this device yet.
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