It was reported that the patient's device was turned off for a mri, and when it was turned back on a "undeliverable output current" warning was received.It was confirmed that (b)(4) software was being used.After re-interrogating and performing system diagnostics, the issue resolved and diagnostics were normal.Internal testing and data review identified that false low output current messages can occur when m3000 (b)(4) software programs a m103-106 generator after a specific programming sequence occurs.When m3000 (b)(4) tablets initiate a programming session with a m103-106 generator, where its output current is programmed off (0 ma), and then the output current is programmed back on to >0 ma, a low output current message would be seen when an in-session interrogation is performed.This would persist upon multiple in-session interrogations and if diagnostics weren't performed during the session, show on the session report.Running system diagnostics or ending and restarting the session will confirm functionality of the device, and resolve the "output current low" error message.The low output current messages in these cases are false and do not impact generator function.Based on the reported programming sequence that occurred that day, it was consistent with the false low output current mechanism described above.Therefore, the patient's generator is expected to be able to deliver therapy as programmed.No further relevant information has been received to date.
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