Intellis AdaptiveStim Spinal Cord Stimulator unable to reprogram
Medtronic Neuromodulation recalls the Intellis AdaptiveStim spinal cord stimulator because one device cannot be reprogrammed. Patients should consult their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for a functional defect (inability to reprogram) affecting spinal cord stimulation therapy. While no injuries or illnesses have been reported, a stimulator that cannot be reprogrammed represents a risk-of-harm scenario where therapy parameters cannot be properly adjusted.
Plain-English summary
Medtronic Neuromodulation is recalling the Intellis AdaptiveStim Product Number 97715 spinal cord stimulator. This device delivers electrical stimulation to the spinal cord to help manage chronic pain.
The recall was initiated because of an inability to reprogram one device. This functional defect means the affected device cannot be adjusted or reprogrammed as needed for patient therapy.
This device was distributed internationally in the United Kingdom. Patients who have received this device should contact their healthcare provider for further information and guidance.
Anyone with this device should speak with their doctor or healthcare provider immediately regarding options, including device evaluation or replacement if necessary.
The recalled product
- Product
- Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- reprogramming-failure
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI/DI 00643169781719
Distribution
Distribution scope not specified by the agency.
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