Medtronic Neuromodulation has recalled 1,493 units of its Stimulation RC Clinician Programmer Application (Model A71400) because of a software defect. This application is used by healthcare providers during surgical procedures to program Inceptiv and Intellis Pro neurostimulators. The software issue can permanently disable communication with the implanted stimulator if a specific programming sequence is used during surgery. No injuries have been reported, but the failure prevents clinicians from properly managing the implanted device.
A specific sequence of steps during surgery can cause the programmer to permanently lose the ability to talk to the implanted neurostimulator. If this happens, the implanted device cannot be properly adjusted or programmed, which may lead to treatment failure or the need for medical intervention to resolve the communication loss.
Used with Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators.
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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