Related manufacturer report number: 2017865-2018-16470.
During an implant procedure, there were insertion difficulties noted while inserting the left ventricular (lv) lead into a lateral vein and there were high pacing thresholds and phrenic nerve stimulation.
The lead was being repositioned when the patient became hypotensive.
An echocardiogram was performed, revealing a pericardial effusion which was treated with a pericardiocentesis.
The lv lead was removed, the implant procedure was abandoned, and a cardiothoracic surgeon performed a thoracotomy to resolve the effusion.
It was suspected that the decrease in blood pressure was due to the anticoagulant therapy of the patient.
The patient was transferred to the intensive care unit and is currently stable.
There were no performance issues noted with any abbott devices during the procedure.
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