Related manufacturer reference number : 2938836-2019-03642, related manufacturer reference number : 2938836-2019-03644.It was reported that the patient was implanted with a biventricular implantable cardioverter defibrillator on (b)(6) 2018 with the left ventricular lead turned off due to the indication of torsade with symptoms of abdominal pain, nausea and vomiting.Catheterization was performed, and minor lesions were noted.The ejection fraction was low (30 to 35%) and it was suspected that it was due to takotsubo cardiomyopathy.The patient presented for follow up after four weeks and it was noted that the ejection fraction was 60 to 65% with the left ventricular lead that was turned off.During third month follow up, it was noted that both the right ventricular (rv) and the right atrial (ra) lead was dislodged into the right atrium.On (b)(6) 2019, the right ventricular leads exhibited decrease in sensing and loss of capture.Loss of capture was also noted on the left ventricular lead.A chest x-ray was performed which confirmed dislodgement of right ventricular and left ventricular leads into the atrium.It was observed that the atrial lead position was not changed.Tachy and pacing therapies were disabled.The atrial lead remained implanted.An echocardiogram was performed which indicated a low ejection fraction (48%).On (b)(6) 2019, the left ventricular and the right ventricular leads were explanted.The right ventricular lead was replaced.The patient presented for follow up in clinic post procedure on (b)(6) 2019 and was stable.
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