Customer Communications

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Type Product Date Document
Education Brief Azure™ and Astra™ pacemakers, and Percepta™, Serena™ and Solara™ CRT-P 2023-Apr Product Education Brief: Alert Threshold for Lead Impedances
Advisory LINQ II Insertable Cardiac Monitoring Systems 2021-Jun LINQ II - Brady, Pause and PVC Detections Disabled Following Electrical Reset SN 21-Mar-2022
Advisory 6930, 6931, 6948, 6949 Sprint Fidelis Defibrillation Leads 2007-Oct Potential Conductor Wire Fracture
Education Brief Micra TPS devices 2021-Nov Procedure Education Brief: Micra TPS Implant
Advisory Cobalt™ XT, Cobalt™ and Crome™ ICDs and CRT-Ds 2022-Jun Potential for Intermittent-Reduced-Energy Shock Due To Short Circuit Protection Event (2022)
Advisory CareLink SmartSync™ Device Manager supporting Cobalt™ and Crome™ ICDs and CRT-Ds 2022-Apr Software Update Available to Correct Potential for SmartSync Telemetry Error
Advisory Subset of ICDs and CRT-Ds 2021-Feb Potential for Shortened RRT-to-EOS in Subset of ICDs and CRT-Ds
Advisory Azure/Astra DR and SR Pacemakers and Percepta/Serena/Solara CRT-Ps 2021-Apr Unipolar Longevity Estimation Software Error
Advisory Reveal LINQ with TruRhythm Insertable Cardiac Monitoring Systems 2021-Jun Reveal LINQ with TruRhythm - Brady & Pause Detections Disabled Following Electrical Reset
Performance Note Azure™ and Astra™ pacemakers, and Percepta™, Serena™ and Solara™ CRT-P 2019-May Performance Note: Potential for no output/no telemetry condition in subset of IPG and CRT-P products due to ceramic capacitor leakage pathway
Advisory Subset of IPG, ICD, CRT-P, CRT-D, and Micra TPS devices - June 2020 2020-Jun CFx Longevity Estimator Software Error - Software Updates Available June 2020
Advisory Cobalt™ XT, Cobalt and Crome™ ICDs and CRT-Ds 2023-May Increased Potential for Reduced Energy or No Energy Delivered During HV Therapy When Programmed AX>B (2023)
Advisory Claria, Amplia, Compia, Viva, Brava, Visia AF, Evera, Primo, Mirro ICDs & CRT-Ds 2023-May Increased Potential for Reduced Energy or No Energy Delivered During HV Therapy When Programmed AX>B (2023)
Advisory LINQ II Insertable Cardiac Monitoring Systems 2023-Nov LINQ II ICM Potential for Amplified Noise

 

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