(b)(4).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
|
It was reported that a male patient underwent left idiopathic ventricular tachycardia (idvt) ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and suffered heart block requiring a temporary pacemaker implantation.It was reported by the caller that while performing a left sided idiopathic premature ventricular contraction (pvc) procedure they had bumped the right bundle causing a right bundle branch block and then when in the left ventricle they bumped the left bundle causing complete heart block.A temporary pacemaker was inserted, and the patient was transferred to the critical care unit.The patient remained stable.There is no information about the hospitalization.The physician did not provide a causality opinion for the cause of this adverse event.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
|