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Product Date Document
EnTrust® VR/DR/AT ICDs 2012-Mar Potential Rapid Battery Depletion
Subset of IPG, ICD, CRT-P, CRT-D, and Micra TPS devices 2019-Oct CFx Longevity Estimator Software Error
Viva™ CRT-D and Evera™ ICD 2016-Aug Potential Rapid Battery Depletion Due To Circuit Component
All models of Claria MRI CRT-D SureScan and Amplia MRI CRT-D SureScan devices. 2016-Dec Potential Loss of Left Ventricle Pacing Due to Software Issue
ICD Leads 1996-Jul Performance Note: Clinical Management of High-Voltage Lead System Oversensing
ICD Leads 1997-Jan Performance Note: General Follow-Up and Replacement of ICD Leads
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
Subset of ICD and CRT-D Devices 2019-Nov Performance Note: Potential For Premature Battery Depletion in a Subset of ICD and CRT-D Devices
Percepta™ CRT-P MRI SureScan™ and Percepta™ Quad CRT-P MRI SureScan™ 2018-Jun Potential for Device Reset
EnTrust® and Escudo® VR/DR/AT ICDs 2018-Jun Potential Loss of High Voltage and ATP Therapy
6930, 6931, 6948, 6949 Sprint Fidelis Defibrillation Leads 2007-Oct Potential Conductor Wire Fracture
Amplia, Claria, Compia, and Viva CRT-D, and Evera and Visia ICD 2018-Jan Potential Loss of Device Functionality
Amplia, Claria, Compia, and Viva CRT-D, and Evera and Visia ICD 2018-Mar Potential Loss of Device Functionality Lower Risk Subset
Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron A, E, G, Q series 2019-Jan Dual Chamber IPG Circuit Error
Chronic Pacing Leads 1992-Jan Performance Note: Tests and Observations for Clinical Assessment of Chronic Pacing Leads
Kappa 700 and other IPGs equipped with the VCM algorithm 2008-Jul Performance Note: Clinical Management of VCM near Elective Replacement
InSync® III Model 8042 2015-Nov Potential High Battery Impedance

 

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