Medtronic Neuromodulation has recalled 1 unit of the Intellis AdaptiveStim (Product Number 97715) Spinal Cord Stimulator due to a report of the inability to reprogram the device. This defect prevents healthcare providers and patients from adjusting the stimulator's settings as needed for pain management. The affected device was distributed internationally in the United Kingdom.
If the device cannot be reprogrammed, the patient may lose the ability to manage their pain effectively or may be stuck at a stimulation level that is uncomfortable or ineffective. This failure of the device interface requires medical intervention to address the programming issue.
Contact healthcare provider or manufacturer
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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