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.
데이터 추가 비고
Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
원인
The pulse generators have a lower battery longevity than specified in their design requirement as a result of the devices being inadvertently left in a programmed on state during manufacture.
조치
On 03/6/2015, the recalling firm sent a recall notification letter to their consignees. The letter included an effectiveness card which is to be signed by the consignee and returned to the recalling firm.