Surgery for gerd and hiatal hernia took place at (b)(6) on (b)(6) 2020 inserting linx device.Pt dc'd (b)(6) 2020.Pt readmitted with serious internal bleeding on (b)(6) 2020.After 2 blood transfusions pt dc'd on (b)(6).Pt struggled w/ dysphasia, nausea and vomiting.Pt readmitted to hospital on (b)(6) 2020 after vomiting blood - gi bleeding.Egd procedure showed that 2 beads from the linx device has eroded into esophagus.Egd procedure showed that at least 2 beads from the linx device had eroded into the lumen at ge junction.Fda safety report id# (b)(4).
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