On january 15, 2024, a patient contacted an impulse dynamics field representative due to an a9 error code displaying on their optimizer smart mini (osm) implantable pulse generator (ipg) charger.The patient was advised to schedule an in-office visit with their doctor.The patient was seen in-office on (b)(6) during which the ipg was reset and interrogated.The latter 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 currently under fda review.
|