On (b)(6) 2023, a patient contacted impulse dynamics technical support because their optimizer smart mini device had entered "ccm down mode" according to the display on their ipg charger.The patient's device was reset, reprogrammed, and interrogated by impulse dynamics field staff.The interrogation of the patient's ipg yielded a "telemet error: down_charge_current_too_high" error.Analysis of the ipg log files confirmed this is the same, known high charge current issue that has affected several other ipgs, and the patient was advised to charge their ipg only to 75 percent battery capacity (3 of 4 bars displayed on the charger) to avoid the ipg entering down mode again.The patient agreed and has continued to receive ccm therapy as normal since this advisement.The permanent fix for this issue will be implemented as part of a future firmware update that is currently pending finalization before being submitted to fda for review and approval.
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