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.
Potential for battery to delivery less than full amount of energy.
조치
The firm issued an 'URGENT - VOLUNTARY MEDICAL DEVICE' recall letter dated 2/21/03 to the physicians. This letter explains the issue and recommends scheduling an immediate follow-up with the patients.
The letter describes conditions under which the patient should be monitored on a weekly basis (versus every 3 months), and under which conditions the device should be explanted.
Biotronik Inc, 6024 Jean Road, Lake Oswego OR 97035-5369
제조사 의견
Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.