On (b)(6) 2023, a patient contacted impulse dynamics technical support because their optimizer smart mini device had entered ccm down mode and was displaying an a09 error code according to the display on their ipg charger.The patient's device was interrogated by impulse dynamics field staff, which yielded a "telemet error: down_ temperature_integrity 4" ipg error.The device was reset, reprogrammed, and updated to run the latest (v1.9.1) ipg firmware.After the reset and update, ccm therapy was observed to be delivered as intended.However, on (b)(6) 2023, the patient reported another a09 error code displaying on their charger.Interrogation of the ipg yielded a ''down_charge_current_too_high" error, and revealed the ipg had been in down mode since (b)(6).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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