KENDALL

Additional Manufacturer Narrative

SECTION D UNIQUE IDENTIFIER (UDI) # WAS CORRECTED FROM (B)(4).

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY ENCOUNTERED AN ISSUE WITH A SET OF DISPOSABLE LEADS THE MORNING OF (B)(6) 2026. THEY STATED THAT THE DISPOSABLE LEADS WERE PERSISTENTLY ALARMING FOR VTACH, AND INTERMITTENTLY APPEARED TO BE A TRUE VTACH ON THE MONITOR. ACCOUNT REPOSITIONED THE LEADS WITH NO CHANGE. ON ACQUIRING A FORMAL EKG, THE PATIENT WAS IN CLEAR NORMAL SINUS RHYTHM. AFTER REPLACING THE ENTIRE LEAD SET (INCLUDING THE TRUNK CORD) THE RHYTHM ON THE MONITOR MATCHED THE NSR ON THE EKG. ECG READING IS ATTACHED. PER THE CUSTOMER ON (B)(6) 2026 THE PATIENT EXPERIENCED UNDUE ANXIETY AND THIS PULLED THE ENTIRE MEDICAL TEAM AWAY FROM OTHER ROUTINE CARE.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.