Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator

Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation shock therapy.

On 07/09/2018, Urgent Field Safety Notices were mailed via certified postal service to physicians informing them about the removal of the non implanted Platinium devices that may present with this hardware failure and providing recommendations for managing implanted patients, which includes patient follow-up one month after discharge, and then every three months until the device nears the replacement date. Follow-up should include checking for battery status and system warnings. The firm recommends that patients be enrolled in remote monitoring. Physicians were instructed to fill out Customer Reply forms and ensure that all personnel involved in the management of patients implanted with affected devices are aware of the information outlined in the notice. For further assistance the firm provided 877-663-7674.