CALA KIQ

Description of Event or Problem

A HEALTHCARE PROVIDER'S OFFICE REPORTED THAT A PATIENT WAS HOSPITALIZED WITH AFIB REQUIRING A CARDIOVERSION AFTER USING THE DEVICE. THE PATIENT STOPPED USING THE DEVICE DUE TO THIS ISSUE. THE PATIENT'S SPOUSE REPORTED A HISTORY OF AFIB AND UNCERTAINTY ABOUT WHETHER THE RECENT EPISODE WAS CAUSED BY DEVICE USAGE. INITIALLY, THE PATIENT USED THE DEVICE REGULARLY WITHOUT ISSUE AND WISHED TO CONTINUE USE DUE TO FAVORABLE RESULTS WITH THE THERAPY, PENDING THE HEALTHCARE PROVIDER'S RECOMMENDATION. THE HEALTHCARE PROVIDER SUBSEQUENTLY RECOMMENDED THAT THE PATIENT RETURN THE DEVICE AND DISCONTINUE SERVICE. THE RETURN AND CANCELLATION WERE PROCESSED, AND THE SPOUSE WAS INFORMED ABOUT THE RETURN PROCESS.