URGENT | 合法醫療器材資訊網

Read More

A Product Advisory is a voluntary letter issued to inform physicians of an anomalous device behavior identified by Boston Scientific's Quality System. Read More

1US Emblem S-ICD survival probability data published in the Q3 2019 PPR available online at www.BostonScientific.com/ppr. Page 2. Advisory subset of ~400 EMBLEM ... Read More

Summary. • Approximately 47,000 EMBLEM S-ICD1 Subcutaneous Electrodes (Model 3501) have been distributed worldwide since 2017 with an overall survival ... Read More

2020年12月2日 — Enclosed is a list of affected EMBLEM S-ICDs associated with your patients. To determine if a device is included in this or any other advisory, ... Read More

Learn if a specific device is affected by a current product advisory issued to physicians by Boston Scientific Cardiac Rhythm Management. Read More

As the world's only subcutaneous implantable cardioverter defibrillator, the EMBLEM S-ICD System protects patients from sudden cardiac arrest (SCA). Read More

2021年2月10日 — Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode (Model 3501) Due to Risk of Fractures ... The FDA has identified this as a Class I ... Read More

2020年12月3日 — Safety Advisories Regarding Boston Scientific Emblem S-ICD · An Elevated Likelihood of a Low Voltage Capacitor Causing Accelerated Battery ... Read More