A voluntary medwatch was submitted to the fda and received by the manufacturer with the report number mw5062653.It was reported that after the patient's initial vns implant, which occurred on (b)(6) 2010, that the patient had worsening depression and the device malfunctioned and could be fatal.It was noted that this first implant was constantly malfunctioning and left scar tissue, which caused death/resuscitation in the operating room.It was reported the device caused a stroke two times, and caused permanent damage to the heart/body.The manufacturer's internal databases were reviewed; however, the patient information was unable to be identified based on the lack of information reported on the voluntary medwatch.Additional information related to a second implanted vns is captured in mfr.Report # 1644487-2016-01519.
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