Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models. Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.

A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

The firm, Medtronic, issued an "Urgent Medical Device Correction" letter dated February 2021 to its consignees in the United States via UPS 2-day delivery. The letter described the product, problem and actions to be taken. Medtronic recommends the customers do the following: Continue normal follow-up per local clinical protocol. o Recognize that patients who require significant pacing support and high voltage therapy have the lowest risk for this issue - See Appendix A for additional details. o Where possible, take advantage of the CareLink" home monitoring system and the wireless low battery voltage CareAlert. o The low battery voltage audible alert is shipped On with high-urgency tones; Remind patients to contact their clinic if they hear an audible alert, particularly since patients may be opting to delay clinic visits due to COVID-19 guidance. o Inform a Medtronic Representative of any unexpected device behaviors. o Be aware that the inability to interrogate the device, or to transmit data, may be an indicator that the device has experienced this issue. If unexpected RRT is observed, prompt replacement of the device should occur commensurate with the underlying clinical situation of the patient: o For non-pacing dependent patients or for primary prevention ICD patients, replacement within 1 week of an unexpected RRT notification is recommended. o For pacing dependent patients, immediate replacement is recommended following an unexpected RRT notification. Note: For all patients, this issue can also manifest as an unexpected change in the remaining longevity estimate that cannot be attributed to programming changes, or changes in use conditions. Medtronic medical staff in consultation with the IPQP recommends against prophylactic replacement due to the low rate of occurrence and the low potential for permanent harm when prompt replacement occurs in response to an unexpected RRT. Please complete the enclosed Clinician Confirmation Certif