D
Patient 1
DURING THE PROCEDURE THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. DR. (B)(6) WHO PLACED THE TEMPO LEAD STATED THAT HE BELIEVED THAT THE PERFORATION OCCURRED DURING THE INITIAL PLACEMENT OF THE TEMPO LEAD. THIS IS SUPPORTED BY HIS STATEMENT THAT THE TEMPO LEAD WAS PLACED "WAY OUT" TO THE APEX OF THE RIGHT VENTRICLE AND IN SPITE OF THIS TYPICALLY OPTIMAL POSITION, PACE CAPTURE COULD NOT BE ATTAINED. DR. (B)(6) REPOSITIONED THE TEMPO LEAD TWICE AND WAS ULTIMATELY ABLE TO OBTAIN A CAPTURE THRESHOLD BELOW 1MA (GENERALLY CONSIDERED OPTIMAL). SUBSEQUENT TO PLACEMENT OF THE LEAD THE PATIENT WAS NOTED TO BE HYPOTENSIVE, WHICH WAS ULTIMATELY DETERMINED TO BE RELATED TO A PERICARDIAL EFFUSION. SURGERY WAS PERFORMED ON THE PATIENT TO CLOSE A SMALL PERFORATION IN THE APEX OF THE HEART. DR (B)(6) STATED THAT HE USED THE INTRODUCER AID TO ADVANCE THE TEMPO LEAD INTO THE INTRODUCER SHEATH AND THAT HE DID NOT HAVE ANY DIFFICULTY DURING TEMPO LEAD INSERTION OR PLACEMENT. HE STATED THAT THE SOFT TIP LOOKED NORMAL AT THE TIME OF THE FINAL POSITION IN THE APEX OF THE RIGHT VENTRICLE AND WAS NOT KINKED OR "OFFSET". HE ALSO STATED THAT THE PATIENT WAS (B)(6) AND AT RISK OF AN APICAL PERFORATION BY VIRTUE OF HIS AGE AND MORBIDITIES. WHILE THE SOFT TIP OF THE TEMPO LEAD APPEARED TO BE DAMAGED, IT IS NOT KNOWN IF THE DEVICE MALFUNCTIONED OR IF THERE WAS MISUSE OF THE DEVICE.