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Type of Product	Medical Device
TGA Recall Reference	RC-2022-RN-00811-1
Product Name/Description	Medtronic Cobalt XT, Cobalt and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) Multiple model numbers ARTG's 339481, 339482, 339483, 339484, 339485, 339486, 339487, 339488, 339489, 339490, 339491, 339492, 341547, 341548, 341549, 341551, 341552, 341555, 341556, 341557, 341558, 341553, 341550, 341554
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	21/06/2022
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	Medtronic is notifying health care professionals of the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). Through 03 June 2022, Medtronic has identified 27 devices (0.03% of devices distributed worldwide) that have experienced a reduced-energy shock, which is accompanied by a Short Circuit Protection (SCP) alert. Medtronic has not received any reports of permanent harm or death due to this issue to date. Update 11/8/22: Medtronic advises of a software update, application D00U005 version 7.1.1, for CareLink SmartSync Device Managers (SmartSync) that will address an advisory from June 2022 is now available.
Recall Action	Hazard Alert
Recall Action Instructions	Medtronic recommends: · Prophylactic device replacement is NOT recommended. · Remote monitoring with normal frequency of follow-up per clinic protocol, with patients’ next follow-up scheduled in-clinic to allow for device reprogramming (if necessary): o Programming all HV therapies to 40J with a B>AX pathway and Active Can/SVC Coil set with Active Can enabled across all therapy zones. · Contact Medtronic if an RV Defib Lead Impedance Alert reporting zero ohms is observed – as this is an indicator that an SCP event was detected during HV therapy. · Clinicians are advised to refer to the Patient Management Recommendations outlined in the Customer Letter (supplied to impacted HCPs by Medtronic) Update 11/8/2022: Customers are to read the customer letter and follow the directions to install the required software update on all SmartSync tablets in their facility. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	0404 090 297 - Zuben Florence