U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
A change in the automatic capacitor reform schedule during the later portion of the device's useful life can result in excessive 750v charge times and disable the device's ability to report an end of life (eol) indicator due to excessive charge times unless the patient is receiving periodic 750v therapy shocks.
조치
Angeion notified physicians responsible for managing each remaining implanted ICD, also provided them with programming means to change the automatic cap charging schedule, and to monitor and document the reprogramming process.
AZ, CA, GA, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, PA and to UK, Italy, Germany and Argentina.
제품 설명
Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2012 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support.