Medtronic Neuromodulation is recalling 7,667 units of the Restore Clinician Programmer Application (CP App), Model A71100, which is used by healthcare providers to manage implanted pain-relief stimulators. A software error can cause a "Device Reset" message to appear on the app that cannot be cleared, which prevents therapy from being resumed. If this occurrs, a patient's pain symptoms may return, and the implanted device itself may require surgical replacement to restore function. This recall specifically affects the clinician application software used on tablets, not the implanted devices themselves.
The software defect can prevent therapy from being restarted after a system reset, leading to the recurrence of chronic pain symptoms. In some cases, the only way to resolve the software-induced lockout is through surgical replacement of the implanted neurostimulator.
All software versions prior to v.1.0.4489 are affected. The implanted devices are not affected.
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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