DURING A RETROACTIVE REVIEW OF PAST TREATMENT EVENTS FOR POTENTIAL ADVERSE EVENTS, CONDUCTED AS A CAPA IN RESPONSE TO A RECENT FDA INSPECTION, A REPORTABLE ADVERSE EVENT WAS DISCOVERED. A (B)(6) YR OLD FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A TREATMENT HAD BEEN DELIVERED WHILE SHE WAS EXERCISING. REVIEW OF THE EVENT INDICATES THAT THE PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION. MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE PATIENT REPORTEDLY WAS ATTEMPTING TO RESPOND TO THE ALARMS. REVIEW OF THE DOWNLOADED DATA INDICATES THAT THE RESPONSE BUTTONS WERE PRESSED AFTER THE TREATMENT WAS DELIVERED. THE PATIENT VISITED THE ER AND CONTINUED USE OF THE LIFEVEST.
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Patient 1
THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION EVENT. DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) AND BELT SN (B)(4) WAS COMPLETED. THE MONITOR AND ELECTRODE BELT WERE FULLY FUNCTIONAL AND ABLE TO DETECT AND TREAT. DEVICE MANUFACTURE DATE: ELECTRODE BELT: 04/2013. INAPPROPRIATE DEFIBRILLATIONS ARE AN ANTICIPATED RISK ASSOCIATED WITH THE USE OF THE LIFEVEST. PATIENTS ARE INSTRUCTED THROUGH ALARMS, VOICE MESSAGES, IFU, AND TRAINING TO PRESS THE RESPONSE BUTTONS TO PREVENT AN INAPPROPRIATE DEFIBRILLATION. (B)(6). A SUMMARY OF THE SAFETY AND EFFECTIVENESS DATA (SSED), INCLUDING THE INAPPROPRIATE DEFIBRILLATION SAFETY OBJECTIVE SUPPORTING FDA'S APPROVAL OF THE LIFEVEST, CAN BE FOUND AT HTTP://WWW.ACCESSDATA.FDA.GOV/CDRH_DOCS/PDF/P010030B.PDF.