Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY

Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of stimulation may result in loss of therapy.

On May 16, 2024 and May 24, 2024, Abbott issued a "Urgent Medical Device Recall" notification to affected consignees informing them to discontinue implanting affected devices and returned affected devices. On August 8, 2024, Abbott issued a "Urgent Medical Device Recall update (Update)" notification informing consignees that a system update was available to correct the issue with Liberta RC" DBS System stimulation turning off at approximately 50-day intervals. . Abbott asked consignees to take the following actions: 1. What to expect during your appointment: "Your Patient Controller application(s) will be updated to the latest version. "The wireless update to your generator is expected to take about 15 minutes to complete. "During the update, your therapy will be turned off for a short time (approximately 5 minutes). "After update, the generator will turn therapy back on at your previously programmed settings. "If the generator update is interrupted or unsuccessful, the process will need to be repeated. 2. After your appointment, if necessary, update your patient controller application: "If you did not bring your PC to your appointment, your Abbott representative will follow-up to support update to the PC application. NOTE: You will not be able to control your device using the PC until the PC application is updated. 3. For additional questions, please contact your Abbott representative or Abbott Technical Support at 1-800-727-7846. 4. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.