On (b)(6) 2023 a patient contacted an impulse dynamics field representative stating the charger used for charging their implantable pulse generator (ipg) device was showing an a9 error code and would not charge the ipg.It was then reported on (b)(6) 2024that the patient's ipg was interrogated and reset by the id field representative when the patient returned for a follow-up visit.Interrogation of the 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 (charger displays 2 of 4 bars as solid with the third bar blinking) 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 currenuy under fda review.
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