CRM Product Advisories
A Product Advisory is issued proactively to inform healthcare professionals about any anomalies that we’ve identified in our devices that might pose a risk to patient safety. The advisories provide you with guidance on recommended or necessary actions in order to mitigate any risks and improve patient outcomes and safety. When a product advisory is issued, BIOTRONIK works to inform all relevant physicians involved in the care of potentially affected patients.
March 2021: Potential premature battery depletion in a subset of ICD and CRT-D devices
BIOTRONIK has become aware of an increased likelihood of premature battery depletion in a subset of devices of the following models of Implantable Cardioverter Defibrillators (“ICDs”) and Cardiac Resynchronization Therapy Defibrillators (“CRT-Ds”).
November 2020: Implantable Cardioverter Defibrillator (ICD)
BIOTRONIK has identified a rare but potentially serious issue with the battery in 24 devices.