As reported in a research article, a patient had nausea and unconsciousness, as well as cardiac tamponade, pericardial effusion, and device explant due to erosion.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.
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Reference manufacturing report number: 2135147-2019-00393, 2135147-2019-00394, 2135147-2019-00395, 2135147-2019-00396, 2135147-2019-00397, 2135147-2019-00398, 2135147-2019-00399, 2135147-2019-00400, 2135147-2019-00403, 2135147-2019-00404, and 2135147-2019-00405.It was reported through a research article identifying an amplatzer septal occluder (aso) that may be related to an explant.Specific patient information is documented as a (b)(6) year old female.Details are listed in the attached article, titled [risk factors and predictors of cardiac erosion discovered from 12 japanese patients who developed erosion after atrial septal defect closure using amplatzer septal occluder].It was reported through the literature that an aso was implanted.The patient developed erosion, with the eroded site at the left atrium roof, cardiac tamponade, and pericardial effusion.The patient presented symptoms of nausea and unconsciousness.The patient underwent surgical repair of the eroded sites and extraction of the device 196 days post device implantation without any other complications.
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