It was reported that the patient had two hospital stays, one in (b)(6) 2018 initially for acute congestive heart failure.However, it was later determined that the device was malfunctioning and her device was reprogrammed.The second hospital stay was for an emergency ablation procedure that was performed on (b)(6) 2018.The patient was being checked for fainting and vomiting, and the physician indicated that the 12 lead the t-waves were inverted and her device was not pacing.The patient was admitted to a telemetry unit for 5-6 days, where the device was pacing again once she arrived.She was told that she was having a heart attack however cardiac enzymes were normal.Liver enzymes off and thyroid enzymes were off probably because of dehydration.Additional requests to gain further understanding were unsuccessful.The system remains in-service.
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