CALA KIQ

Description of Event or Problem

THE PATIENT REPORTED THAT APPROXIMATELY 30 MINUTES INTO A THERAPY SESSION, HE WENT INTO ATRIAL FIBRILLATION (AFIB). HE BEGAN TO FEEL CHEST DISCOMFORT FOLLOWED BY DIZZINESS AND DIFFICULTY WALKING, WHICH LED HIM TO DISCONTINUE THE SESSION. THE PATIENT STATED HE OBSERVED A RESTING HEART RATE OF 125 BPM AND "VERY HIGH" BLOOD PRESSURE.THE PATIENT CONSULTED A CARDIOLOGIST THE NEXT DAY, AND WAS PRESCRIBED A 14-DAY CARDIAC MONITOR FOR A SUSPECTED EPISODE OF ATRIAL FIBRILLATION (AFIB). CALA IS CURRENTLY IN COMMUNICATION WITH THE PATIENT TO OBTAIN THE NECESSARY SUPPLEMENTARY INFORMATION.

Additional Manufacturer Narrative

DIAGNOSTIC STATUS: WHILE THE PATIENT REPORTED AN EPISODE OF ATRIAL FIBRILLATION (AFIB), CALA HAS NOT YET RECEIVED FORMAL DIAGNOSTIC CONFIRMATION FROM THE TREATING CARDIOLOGIST. PENDING DATA: THE RESULTS OF THE 14-DAY CARDIAC MONITOR AND THE FULL CARDIAC WORKUP RESULTS AND ADDITIONAL INFORMATION ARE CURRENTLY PENDING. CLINICAL INVESTIGATION DELAY: CALA HEALTH SENT THE MEDICAL COMPLAINT FOR REVIEW BY A LICENSED NEUROLOGIST, WHO REQUESTED ADDITIONAL MEDICAL HISTORY INFORMATION FROM THE PATIENT TO COMPLETE THE EVALUATION. HOWEVER, THE COMPLETION OF THIS EVALUATION HAS BEEN DELAYED AS THE PATIENT WAS INITIALLY HESITANT TO RELEASE MEDICAL RECORDS PENDING A REFUND REQUEST. CURRENTLY, THE REFUND REQUEST HAS BEEN RESOLVED AND FOLLOW-UP EFFORTS ARE NOW ONGOING. DEVICE INVESTIGATION: THE RETURNED DEVICE WAS TESTED AND FOUND TO BE FULLY FUNCTIONAL. A REVIEW OF THE DEVICE LOGS SHOWED NO EVIDENCE OF MALFUNCTION OR TECHNICAL ISSUES. RISK ANALYSIS CONTEXT: CALA HAS RECEIVED A TOTAL OF TWO MEDICAL DEVICE REPORTS AND THE CURRENT REPORT CONCERNING ATRIAL FIBRILLATION (AFIB) REQUIRING MEDICAL INTERVENTION OUT OF APPROXIMATELY (B)(4) SHIPPED CALA KIQ UNITS. THIS CORRESPONDS TO AN OBSERVED FREQUENCY OF 0.014%, OR APPROXIMATELY 1 IN (B)(4) UNITS, WHICH REMAINS CONSISTENT WITH THE "REMOTE" PROBABILITY CATEGORY (LEVEL 2: LESS THAN 1 IN 1,000, BUT MORE THAN 1 IN 10,000 FAILURES) DEFINED IN THE DEVICE HAZARD ANALYSIS (RSK-11014). THE OBSERVED SEVERITY AND FREQUENCY OF THIS EVENT ARE CONSISTENT WITH THE PREDEFINED RISK SCENARIOS AND EXPECTATIONS DESCRIBED IN THE DEVICE'S RISK MANAGEMENT DOCUMENTATION (RISK IDS 5.1.44 AND 5.1.54). CONCLUSION: CALA CONCLUDES THAT THE FREQUENCY AND SEVERITY OF THIS EVENT ARE CONSISTENT WITH EXPECTATIONS DESCRIBED IN THE DEVICE'S RISK MANAGEMENT DOCUMENTATION. NO NEW TRENDS OR UNEXPECTED PATTERNS HAVE BEEN IDENTIFIED TO DATE.