[177841337]
Patient's date of birth unavailable. Patient's weight unavailable. Device lot number, expiration date unavailable. Device manufacture date unavailable because lot number is unavailable.
Patient Sequence No: 1, Text Type: N, H10
[177841338]
A complex lead extraction procedure commenced to remove three leads: two right ventricular (rv) leads and one right atrial (ra) lead due to non function and one redundant rv lead. The patient had three separate and distinct venous entry sites in the subclavian vein, one for each lead which had been implanted. Several different devices were in use to aid in the extractions of the three very heavily fibrosed leads, and several devices entered and exited the subclavian entry sites during extraction. During the procedure, the patient did not exhibit any hemodynamic changes, such as a drop in blood pressure. However, after the leads had been extracted, it was noted that there was persistent bleeding from the pocket. Per report, the cardiac surgeon was in the procedure room at least the last 30 minutes of the extraction procedure. Ultimately, a rescue device was used to provide hemostasis to the subclavian area while the decision was made to perform a sternotomy. Once in the chest, the surgeon confirmed that there was no additional injury to the subclavian region other than dilatation of the entry sites due to the extraction tools used, which is part of the clinical lead extraction procedure. However, the physician discovered injuries in the right atrial wall and in the right ventricle. It was reported that the patient's tissues were very thin but repairs were successful. However, when patient was taken off pump after surgery, her heart stopped and she expired. It was noted that the patient had a previous sternotomy performed (reason unknown). However, the likely reason that the patient did not exhibit hemodynamic compromise is that the pericardium was stuck to the myocardium from adhesions, preventing any pericardial effusion, per thoughts from philips senior medical advisor/cardiologist. There was no delay in obtaining blood or performing the sternotomy; the lead extraction procedure was performed in the operating room. This report captures the rv perforation in which a spectranetics lead locking device (lld) was used inside the rv lead as the lead's traction platform (please refer to mdr 1721279-2020-00022 which captures the ra wall injury). Attempts continue to obtain further information regarding the patient's medical condition prior to the procedure.
Patient Sequence No: 1, Text Type: D, B5