ZIO AT

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO IRHYTHM, AND THE CLINICAL DATA WAS DOWNLOADED. A REVIEW OF THE CLINICAL DATA REVEALED THAT THE DEVICE WAS WORN FOR THE 9 DAYS OF THE 14-DAY PRESCRIBED WEAR PERIOD. ON DAY 4, THE HCP ACCOUNT WAS NOTIFIED THAT THE DEVICE WAS APPROACHING THE ASYMPTOMATIC TRANSMISSION LIMIT, A REPLACEMENT DEVICE WAS SHIPPED. THE DEVICE REACHED THE ASYMPTOMATIC MAXIMUM TRANSMISSION LIMIT AND STOPPED TRANSMITTING ASYMPTOMATIC EVENTS ON DAY 5. IRHYTHM BECAME AWARE OF THE ARRHYTHMIA WHILE PREPARING THE FINAL REPORT AND NOTIFIED THE HCP ON DAY 25. AS DESCRIBED IN THE PRODUCT LABELING, THE ZIO AT DEVICE HAS A MAXIMUM THRESHOLD OF TRANSMITTING 100 PATIENT TRIGGERS AND 500 ASYMPTOMATIC TRANSMISSIONS DURING WEAR. WHEN A PATIENT IS APPROACHING THE LIMIT FOR EITHER TRANSMISSION TYPE, IRHYTHM REACHES OUT TO THE ACCOUNT TO DETERMINE WHETHER TO SEND ANOTHER AT DEVICE TO THE PATIENT. PATIENT-TRIGGERED SYMPTOMATIC TRANSMISSIONS ARE STILL ABLE TO BE TRANSMITTED BEYOND THIS LIMIT BY PRESSING THE LARGE CENTRAL BUTTON LOCATED ON THE OUTER DEVICE HOUSING. THE TRANSMISSION LIMIT COUNTER IS REFLECTED ON DAILY REPORTS AVAILABLE TO THE HCP AND IN THE ZIO SUITE PORTAL. THIS EVENT IS BEING REPORTED PER 21CFR 803 AS A PRODUCT PROBLEM /MALFUNCTION. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY IRHYTHM THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED. THESE TERMS ARE INCLUDED IN FORM FDA 3500A AND ARE FIXED TERMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING.

Description of Event or Problem

THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION CONFIRMED THE ZIO AT REACHED THE ASYMPTOMATIC MAXIMUM TRANSMISSION LIMIT. THE HEALTHCARE PROVIDER (HCP) ACCOUNT WAS NOTIFIED THAT THE DEVICE WAS APPROACHING THE ASYMPTOMATIC TRANSMISSION LIMIT PRIOR TO REACHING THE LIMIT, ACCORDING TO THE STANDARD PROCESS, AND A REPLACEMENT DEVICE WAS SHIPPED. ADDITIONAL FOLLOW-UP WAS PERFORMED WITH THE ACCOUNT TO NOTIFY OF THE PATIENT'S ARRHYTHMIA. THERE WERE NO DELAYS IN TREATMENT, AND NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.