Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient has been receiving spinal cord stimulation (scs) treatment for neuropathic pain in her left ankle for several years.The ins worked perfectly and relieved the patient's pain very well.In (b)(6) 2021, the patient underwent a new surgical operation on her left ankle.After this surgery, when the patient wanted to restart her stimulation, the ins did not respond to the remote control or the charger.During a consultation with the doctor on (b)(6) 2021 we were unable to establish a connection with the patient's ins.The ins was no longer working.The decision was made to replace the ins.The issue was resolved.The patient was alive with no injury.
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