Description of Event or Problem · 0
A PATIENT REPORTED CONCERNS THAT THE CALA DEVICE MAY HAVE CONTRIBUTED TO A HEART-RELATED HEALTH EVENT. THE PATIENT EXPERIENCED CHEST PAIN WHILE USING THE DEVICE AND SPECULATED ABOUT A POSSIBLE CARDIAC EVENT, DESCRIBING A "SILENT BUT DEADLY HEART ATTACK," THOUGH HE ACKNOWLEDGED THIS MIGHT BE COINCIDENTAL. THE PATIENT ALSO NOTED HAVING A "DEAD LEFT VENTRICLE." THE PATIENT'S WIFE REPORTED THAT THE DEVICE WAS USED CONSISTENTLY FROM THE END OF (B)(6) 2023 TO BEGINNING OF (B)(6) 2024 AND THE PATIENT DISCONTINUED USAGE OF DEVICE AT THE BEGINNING OF (B)(6) 2024 DUE TO WORSENING HEART CONDITION SYMPTOMS. ACCORDING TO THE USAGE DATA FROM THE LOGS RECORDED FROM THE DEVICE, THE DEVICE WAS ONLY USED OCCASIONALLY (4 FULL THERAPY SESSIONS AND 3 PARTIAL SESSIONS) FROM THE END OF (B)(6) 2023 UNTIL (B)(6) 2024. THE PATIENT'S WIFE REPORTED THAT THE PATIENT HAD PRE-EXISTING BUT UNDIAGNOSED HEART ISSUES AND A FAMILY HISTORY OF HEART FAILURE (PATIENT'S MOTHER). THE PATIENT REPORTED SYMPTOMS DURING CALA DEVICE USE INCLUDED LOW ENERGY, EXCESSIVE SLEEPINESS, AND CHEST PAIN. FOLLOWING CESSATION OF DEVICE USE, THE PATIENT REPORTED THEY UNDERWENT EMERGENCY OPEN-HEART SURGERY ON (B)(6) 2024 FOR HEART FAILURE, WHICH WAS SUCCESSFUL. THE PATIENT IS CURRENTLY RECOVERING AT HOME. THE PATIENT'S CARDIOLOGIST, WHO WAS AWARE OF THE CALA DEVICE, DID NOT COMMENT ON ITS ROLE IN THE PATIENT'S CONDITION. THE PATIENT ALSO HAS A HISTORY OF DIABETES.