Class 2 Device Recall BIOTRONIK ITREVIA

• Date Initiated by Firm: March 08, 2021
• Create Date: April 21, 2021
• Recall Status: Terminated on April 25, 2023
• Recall Number: Z-1451-2021
• Recall Event ID: 87549
• PMA Number: P050023S079
• Product Classification: Defibrillator, implantable, dual-chamber - Product Code MRM
• Product: BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
• Code Information: Serial Number 60797220 60797221 60797222 60797223 60797224 60797225 60797226 60797227 60797228 60797230 60797233 60797234 60797235 60797236 60797238 60797239 60797240 60797244 60797245 60798755 60798756 60798757 60798759 60798762 60798764 60798765 60798767 60798770 60798773 60798774 60798775 60798776 60798777 60798780 60798785 60798786 60798792 60798793 60798794 60800603 60800604 60800605 60800607 60800613 60800615 60800618 60800731 60800733 60800736 60800737 60800738 60800740 60800742 60800743 60800744 60800745 60800746 60800778 60800782 60800784 60800786 60800790 60800798 60800801 60800802 60800804 60803291 60803293 60803296 60803297 60803301 60803313 60803315 60803326 60803329 60803330 60803332 60803335 60803720 60803721 60803728 60803732 60803733 60803734 60803736 60803737 60803738 60803749 60803750 60803751 60803753 60803754 60803755 60803758 60803762 60803764 60803768 60807835 60807848 60807849 60807868 60807871 60809002 60809004 60809006 60809008 60809012 60809031 60809032 60809036 60809037 60809038 60809039 60809040 60809042 60809043 60809045 60809046 60810246 60810248 60810250 60810252 60810254 60810255 60810257 60810260 60810261 60810262 60810263 60810265 60812205 60812207 60812211 60812215 60812226 60812227 60812229 60812794 60812795 60812797 60812798 60812801 60814326 60814327 60814329 60814331 60814332 60814333 60814334 60814336 60814337 60814339 60814340 60814341 60814342 60815586 60815598 60815599 60815603 60815605 60815606 60815609 60815611 60815614 60816304 60816307 60816308 60816316 60816318 60816319 60816321 60816322 60816788 60816789 60816790 60816793 60816794 60816795 60816796 60816797 60816799 60816800 60816802 60816803 60816804 60816807 60816809 60816812 60816813 60816814 60818665 60818666 60818667 60818668 60818670 60818671 60818676 60818677 60818678 60818683 60818686 60818689 60818691 60818692 60820141 60820142 60820144 60820146 60820147 60820150 60820152 60820161 60821216 60821217 60821228 60822501 60822502 60822504 60822508 60822514 60823214 60823215 60823216 60823218 60823223 60823231 60823236 60823241 60823242 60823243 60823245 60823247 60823248 60823250 60823550 60823551 60823555 60823556 60823557 60823559 60824544 60824546 60824549 60824550 60824552 60824554 60824565 60825334 60825338 60825340 60825392 60825399 60825407 60825409 60825414 60825415 60825417 60827611 60827613 60827614 60827617 60827618 60827622 60827655 60828085 60828087 60828090 60828092 60828640 60828645 60828647 60828648 60828649 60828650 60828654 60828662 60828663 60828665 60828666 60830068 60830072 60830073 60830074 60830075 60830076 60830079 60830080 60830081 60830083 60830085 60830086 60830088 60830089 60830091 60830092 60830095 60832863 60832875 60835184 60835185 60835186 60835188 60835190 60835193 60835196 60835197 60836874 60836875 60836877 60836878 60836879 60836881 60836882 60836883 60836885 60836886 60836887 60836890 60836891 60836893 60839226 60839227 60839229 60839232 60839234 60839236 60839239 60839242 60841413 60841414 60841427 60841428 60842610 60842611 60842613 60842616 60842617 60842640 60842641 60842642 60842643 60842645 60844472 60844506 60844511 60844535 60844544 60844548 60844550 60844859 60844865 60844866 60846786 60846787 60846788 60846797 60846798 60876471 60876481 60876491 60877621 60878891 60878894 60878896 60878899 60878900 60878902 60878903 60878906 60878912 60878913 60878915 60878921 60878925 60886051 60886052 60886054 60886055 60886062 60886065 60886068 60887136 60887140 60887143 60887147 60887148 60888306 60888315 60890322 60891628 60892871 60892876 60892880 60892885 60892889 60892890 60892891 60892894 60892908 60892918 60892921 60892938 60892940 60892968 60892970 60904991 60904994 60904996 60904999 60905009 60909415 60909416 60909421 60909426 60909432 60909433 60910094 60910099 60910103 60911878 60911888 60911890 60911898 60911900 60911902 60911921 60911949 60913239 60913243 60913260 60915577 60916110 60916111 60916112 60916348 60916350 60916351 60916352 60916353 60916355 60917757 60917758 60917761 60917763 60917764 60917765 60917766 60919524 60919525 60919526 60919528 60919532 60919533 60921035 60921037 60921038 60921039 60921042 60921044 60921046 60921048 60921051 60921053 60921055 60921056 60921057 60922498 60924858 60924859 60924862 60924864 60924868 60924870 60924872 60924873 60924875 60924876 60924878 60924879 60924880 60924885 60925861 60925871 60925874 60931592 60934432 60934433 60934434 60934435 60934440 60934441 60934445 60934448 60934449 60935460 60935461 60935469 60939663 60939664
• 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: 499 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