Product Performance & Advisories Information for Healthcare Professionals

Overview

Medtronic is committed to providing the highest quality products. As part of our commitment, we share important information learned from the ongoing use of our products.

Product Performance Data

We believe in sharing updates with customers on a regular basis by showing the evolution of product performance over time:

• Cardiac Rhythm and Heart Failure
• Neuromodulation Products (US website)

Product Advisories

We believe the content of product advisories will further patient safety:

Cardiovascular Group (CVG)

• October 2019: CFx Longevity Estimator
• August 2019: Delivery System for Micra Transcatheter Pacing System — Instructions For Use Update
• January 2019: Dual Chamber Pacemaker Circuit Error: Initial Physician communication | September 2019 Update: Follow-Up Physician communication
• January 2019: Programmer Software Update Supporting the Micra™ Transcatheter Pacing System
• November 2018: Medtronic HeartWare™ HVAD™ System Battery Charger
• October 2018: Software Distribution Network & Associated Programmers
• August 2018: HeartWare^™ HVAD^™ Controller Housing Integrity
• June 2018 (2012): EnTrust ICDs 2012 | 2018
• June 2018: Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan Pacemakers
• May 2018: HeartWare^™ HVAD^™ System Unexpected Power Source Switching: Initial Communication | Update Communication | October 2019 Update: Concluding Communication
• March 2018: Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Implantable Cardioverter Defibrillators (ICDs)
• February 2018: BIOCAL™ Temperature Controller
• April 2017: Claria MRI CRT-D SureScan and Amplia MRI CRT-D SureScan
• March 2017: Endurant Permeability
• November 2016: Reveal LINQ ICM
• November 2016: Affinity Fusion Oxygenator
• August 2016: Viva CRT-D and Evera ICD
• November 2015: InSync III CRT-P
• November 2015 (2009): Sprint Fidelis Defibrillation Leads: Physician | Patients
• October 2013: Interventional Wires and ATTAIN HYBRID^® GuideWires
• June 2013: Consulta CRT-P and Syncra CRT-P
• February 2010: EnRhythm Pacemakers
• May 2009: Kappa and Sigma Pacemakers

Restorative Therapies Group (RTG)

• Deep Brain Stimulation Systems (including Activa neurostimulators)
• Spinal Cord Stimulation Systems (including Restore neurostimulators)
• Gastric Electrical Stimulation Systems (including the Enterra neurostimulator)
• Sacral Neuromodulation Systems (including InterStim neurostimulators)
• Targeted Drug Delivery Systems (including the SynchroMed II pump)