Class 2 Device Recall BIOTRONIK ILIVIA

• Date Initiated by Firm: March 08, 2021
• Create Date: April 21, 2021
• Recall Status: Terminated on April 25, 2023
• Recall Number: Z-1457-2021
• Recall Event ID: 87549
• PMA Number: P050023S103
• Product Classification: Defibrillator, implantable, dual-chamber - Product Code MRM
• Product: BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
• Code Information: Serial Number 60921641 60921645 60921650 60921654 60921661 60921676 60921681 60924487 60924853 60925463 60925466 60925467 60925469 60925472 60927681 60929676 60929681 60929693 60930725 60930727 60930729 60930730 60931822 60931823 60931827 60931828 60931832 60931843 60931848 60931851 60932793 60932796 60932825 60932833 60932835 60934488 60934503 60935883 60937416 60937431 60937444 60937446 60937448 60937455 60937459 60937461 60937463 60938681 60938682 60940313 60940320 60940326 60940335 60940914 60943117 60944369 60944385 60944388 60944390 60946404 60946430 60948922 60948927 60948928 60949789 60953224 60953232 60955316 60955320 60957532 60957533 60957983 60957986 60965646 60965647 60966818 60966819 60966828 60967662 60967668 60968092 60968093 60968094 60968100 60975060 60975061 60975077 60975096 60977491 60977507 60977560 60978758 60979333 60979341 60984636 60984641 60984642 60984651 60984665 60985083 60985087 60985094 60985097 60985098 60985099 60985100 60985101 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• Recalling Firm/ Manufacturer: BIOTRONIK Inc; 6024 Jean Rd; Lake Oswego OR 97035-5571
• For Additional Information Contact: BIOTRONIK Technical Services; 1800-547-0394
• Manufacturer Reason for Recall: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
• FDA Determined Cause: Device Design
• Action: On 3/8/21, BIOTRONIK issued a "Urgent Field Safety" recall notification to all affected consignees via UPS. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. To determine if a specific device is affected by this corrective action you can lookup the device at the following web address: www.biotronik.com/devicelookup. 2. Devices in stock: Do not implant any potentially affected devices. Local BIOTRONIK representatives will replace affected devices in hospital inventory. 3. Continue with the standard patient follow-up schedule. -During follow-ups: Verify the status of the device and battery during in-office or Home Monitoring follow-ups. Please note that unresponsive devicesor those that are not transmitting data may be experiencing this issue and your BIOTRONIK representative should be informed if you observe any unusual device behavior. -Home Monitoring should be utilized whenever possible as it provides timely ERI warnings to reduce the risk of sudden loss of therapy. If you do not yet use Home Monitoring, please consider if this option is appropriate for you and your patients. BIOTRONIK will provide Cardio Messenger devices to monitor implants affected by this advisory. If you would like to register for Home Monitoring, please contact your local BIOTRONIK representative. 4. If there is an unexpected ERI notification for a device that is subject to this advisory, a timely replacement should be considered based on the patients underlying conditions: - For patients that are not pacemaker dependent, or patients with a primary prevention ICD, device replacement within one week after ERI notification is recommended. - For pacemaker dependent patients, replacement of the device is recommended immediately after ERI notification. 5. In consultation with our medical advisory board, BIOTRONIK does not recommend prophylactic replacement. The risk of complications for ICD exchange1-3 outweighs
• Quantity in Commerce: 914 units
• Distribution: US: Nationwide OUS: Worldwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = MRM and Original Applicant = BIOTRONIK, INC.