It was reported that the patient experienced asthenia.During a follow-up, the device was unable to be interrogated and was not pacing.The patient is pacemaker dependent.The device was explanted and replaced to resolve the event.The device is subject to the zenex, assurity, endurity laser adhesion preparation field safety correction action issued on 20 july 2022, which applies to a subset of devices distributed and implanted outside of the united states.The patient was in stable condition.
|
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record review was performed, and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.
|