Patient weight unavailable.Device lot number and expiration date unavailable.Device manufacture date unavailable.Patient codes: although the patient died in the procedure, the death was unrelated.To the lld being used in the procedure.Therefore, patient code 1802 was not used.Conclusions code 61 was used because the physician did not attempt to unlock the lld prior to cutting and capping the rv lead/lld.
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A lead extraction procedure commenced to remove a right ventricular (rv) lead due to non function.It was reported that the patient's subclavian vein was occluded.The pocket was opened, and the physician removed the generator of the device.The physician then prepped the rv lead with a spectranetics lead locking device (lld) to use for traction.The physician attempted to gain access into the venous vasculature using standard technique.However, during this time, bleeding was noted at the entry site (patient remained stable during this time).It was confirmed from the physician that the bleeding was related to the patient's condition, and that spectranetics devices in use did not cause or contribute to any injury.The bleeding was controlled, and a vascular consult was obtained, in which an arteriogram and venogram were performed.No injury was detected.The physician chose to abandon the procedure.He cut and capped the rv lead and lld within the lead (physician did not attempt to unlock the lld prior to cutting/capping, so there was no confirmation there was any malfunction of the lld).The lld remained within the lead within the patient.The physician then closed the pocket.Approximately an hour after the pocket was closed, the patient's blood pressure dropped and a code was implemented.The patient died; the physician confirmed that her death was related to her condition and was not related to any procedural event (actual cause of death unknown).This report is being submitted for the lld that was cut and capped and left within the patient.
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