On july 3, 2023, a patient's caretaker informed their regional impulse dynamics field representative that the patient's optimizer smart mini device entered ccm down mode due to an a09 error code, according to the display on their ipg charger.On (b)(6), the patient's ipg was reset, reprogrammed, and updated to the latest (v1.9.1) ipg firmware by field staff at the implanting physician's office.Interrogation of the ipg by field staff 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 and caretaker were advised to keep the ipg charged 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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