TEMPORARY PACING LEAD

Description of Event or Problem

THE FOLLOWING WAS PUBLISHED IN THE HEART RHYTHM SOCIETY (1547-5271/© 2024), IN AN ARTICLE TITLED " TEMPORARY-PERMANENT PACEMAKERS ARE ASSOCIATED WITH BETTER CLINICAL AND SAFETY OUTCOMES COMPARED TO BALLOON-TIPPED TEMPORARY PACEMAKERS; MAROUN CHEDID; DOI: 10.1111/PACE.14918. RETROSPECTIVE, CHART REVIEW STUDY EVALUATING ALL PATIENTS WHO UNDERWENT TEMPORARY PACEMAKER PLACEMENT BETWEEN 2014 AND 2022 (N = 126) IN THE CARDIAC CATHETERIZATION LABORATORY (CCL) AT A LEVEL 1 TRAUMA CENTER. PRIMARY OUTCOME OF THIS STUDY IS TO EVALUATE THE SAFETY PROFILE OF TPPM VERSUS BTTP. SECONDARY OBJECTIVES INCLUDE PATIENT AMBULATION AND HEALTHCARE UTILIZATION IN PATIENTS WITH TEMPORARY PACEMAKERS. FOUR VENOUS THROMBOEMBOLISMS AND 14 LEAD DISLODGMENTS OR LOSS OF CAPTURE OCCURRED.

Additional Manufacturer Narrative

THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED THROMBOEMBOLISMS AND LEAD DISLODGMENTS REMAINS UNKNOWN. MODEL/LOT NUMBER INFORMATION WAS NOT ABLE TO BE OBTAINED FOR THIS DEVICE. THEREFORE, FULL UDI INFORMATION(D4) AND 510K(G3) ARE NOT AVAILABLE.