Potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust ICDs

Medtronic International Limited would like to inform healthcare professionals of the potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust implantable cardioverter defibrillators (ICDs) as they near elective replacement indicator (ERI) voltage. Under certain circumstances, the EnTrust ICD may display an immediate End of Life (EOL) Observation with no prior ERI alert. Though no ERI alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, leading to a loss of high voltage and anti-tachycardia pacing therapy. Bradycardia therapies will continue to operate as expected. The rate of occurrence in actively implanted devices is estimated to be 0.00098 in single chamber ICDs and 0.00005 in dual chamber devices. Through June 15, 2018, Medtronic has confirmed 25 charge timeout events related to this issue, with no patient deaths or complications. Healthcare professionals are advised to consider scheduling follow-ups for implanted patients as soon as possible to assess the potential for this issue per steps described, and follow the recommended actions to ensure patient safety and effective high voltage therapy as the device battery voltage approaches ERI threshold. Please refer to the letter for details.