Description of Event or Problem · 0
RELATED MANUFACTURER NUMBER: 2017865-2022-43255. IT WAS REPORTED 28 FEBRUARY, 2023 THAT ATRIAL UNDERSENSING RESULTING IN INAPPROPRIATE ATRIAL PACING WHICH IN TURN CAUSED VENTRICULAR PACING INTO REFRACTORY TISSUE WAS OBSERVED ON THE ATRIAL LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. THE PATIENT WAS BEING MONITORED REMOTELY. FURTHER INFORMATION RECEIVED 12 MARCH, 2023 INDICATES THE PATIENT EXPERIENCED A VENTRICULAR TACHYCARDIA (VT) STORM AND ATTEMPTS TO PACE THE PATIENT OUT OF THE VT STORM WERE MADE. INTERROGATION REVEALED THE PATIENT WAS IN AND OUT OF VT FREQUENTLY BUT NOT IN VT AT THE TIME OF INTERROGATION. IT WAS NOTED THAT THE VT TYPICALLY FELL IN THE VT ZONE WHICH ONLY CONSISTED OF ANTI TACHYCARDIA PACING THERAPY (ATP) BUT THE PATIENT HAD RECEIVED SEVEN SHOCKS THAT MORNING. ISSUES WERE OBSERVED WITH TIMING CYCLE ACCURATELY DETECTING SLOW VT THAT RESULTED IN THE DEVICE DELIVERING SHOCK THERAPY BASED ON VENTRICULAR FIBRILLATION (VF) ZONE PARAMETERS THAT TEMPORARILY BROKE THE RHYTHM. THE PATIENT WAS NOTED TO BE IN ATRIAL FIBRILLATION (AF) THAT WAS BEING UNDERSENSED RESULTING IN INAPPROPRIATE PACING AND RESULTING IN PREMATURE VENTRICULAR CONTRACTIONS (PVCS) BEING BLANKED BY AN ATRIAL ALERT. THE PATIENT'S PROGRAMMED FACE RATE AND SLOW VT ALLOWED THIS OCCURRENCE. SEVERAL PROGRAMMING CHANGES WERE MADE TO ADDRESS THE OBSERVATIONS. THE PATIENT WAS VERY SICK DUE TO THEIR INTRINSIC CONDITION BUT NO STATEMENT WAS MADE INDICATING THEY WERE WORSE DUE TO THE SHOCK THERAPY RECEIVED. THE PATIENT WAS TO RECEIVE ADDITIONAL MEDICATION IN ATTEMPTS TO REDUCE THEIR VT.