It was reported that the patient with this left ventricular (lv) lead experienced infection.Reportedly, the patient had endocarditis with vegetation identified on the lead and the patient had been in respiratory failure and septic shock.A revision was performed and the crt-d along with the right ventricular (rv) lead, right atrial (ra) lead and this left ventricular (lv) lead were explanted.No additional adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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