It was reported that the device was prophylactically explanted and replaced as it is subject to the zenex, assurity, endurity laser adhesion preparation field safety correction action which applies to a subset of devices distributed and implanted outside of the united states.No malfunction was reported, and the patient is in stable condition with no adverse consequences.
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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.
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