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.
Through post-market surveillance, ela medical has observed that a no-output condition could occur in a limited number of symphony or rhapsody pacemakers. the no-output condition could occur due to metal migration caused by a specific manufacturing process.
조치
A Dear Doctor letter, dated 10/25/05, was sent to all affected doctors. The letter describes the failures and mentions that pacemaker depend patients implanted with devices manufactured in the first group could require prophylactic replacement.
Devices distributed with the US to AZ, CA, FL, IL, LA, MA, ME, MO, MS, SC,
제품 설명
ELA Rhapsody SR model 2210. A single chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, 98, rue Maurice Amoux, 92120 Montrouge - France. Made in France.