On (b)(6) 2023, a patient called their regional impulse dynamics field representative because their optimizer smart mini device entered ccm down mode due to an a09 error code, according to the display on their ipg charger.The patient's ipg was reset, reprogrammed, and interrogated by field staff and 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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