Description of Event or Problem · 0
ON (B)(6) 2025 A PREVENTICE (BOSTON SCIENTIFIC) BODYGUARDIAN MINI EL WAS PLACED ON A PATIENT AT (B)(6) HOSPITAL IN THE OUTPATIENT (B)(6). THE DEVICE WAS REGISTERED TO BE PLACED ON THE PATIENT ON (B)(6) 2025 SAME DAY ON THE PREVENTICE WEBSITE. ONCE THE DEVICE WAS PLACED ON THE PATIENT ON (B)(6) 2025, THE PATIENT /FAMILY WERE PROVIDED A RETURN BOX THAT SHIPS DIRECTLY TO PREVENTICE FOR ANALYZATION WITH THEIR OWN STAFF. ONCE THE REPORT IS RETURNED ONE OF OUR TWO PEDIATRIC CARDIAC ELECTROPHYSIOLOGISTS (EP) FINALIZES THE REPORT IN OUR ELECTRONIC MEDICAL SYSTEM, EPIC, AND NOTIFIES THE REFERRING MD OF ANY PERTINENT FINDINGS. DR. (B)(6), OUR PEDIATRIC CARDIAC ELECTROPHYSIOLOGIST'S FINALIZED THE REPORT AND CALLED DR. (B)(6) TO GO OVER THE FINDINGS AS THERE WAS A FINDING OF ATRIAL TACHYCARDIA. THE CARDIOLOGIST DISCUSSED NEXT STEPS, AND THE PATIENT WAS REFERRED TO SEE DR. (B)(6). IN THE MEANTIME, THE PATIENT WAS PRESCRIBED BETA BLOCKERS BASED OFF THE FINDINGS ON THE PREVENTICE CARDIAC MONITOR AND THE SYMPTOMS THAT THE PATIENT HAD SHARED WITH DR. (B)(6) AT THE CLINIC APPOINTMENT ON (B)(6) 2025. ON (B)(6) 2025 THE PATIENT/FAMILY SAW THE PEDIATRIC CARDIAC ELECTROPHYSIOLOGIST IN OUR OUTPATIENT CARDIOLOGY CLINIC (DR. (B)(6)). AS DR. (B)(6) WAS SPEAKING WITH THE FAMILY AT THIS APPOINTMENT, SHE CONFIRMED THAT THE DEVICE WAS PLACED ON THE PATIENT ON (B)(6) 2025 BUT NOTICED THAT THE RESULTS ON THE PREVENTICE REPORT WERE SHOWING THAT THE DEVICE WAS FROM (B)(6) 2025, WHICH COULDN'T BE CORRECT AS THE DEVICE WAS ACTIVATED AND PLACED ON THE PATIENT ON (B)(6) 2025. DR. (B)(6) SHARED HER CONCERNS WITH THE PARENTS THAT THE REPORT STATES A DIFFERENT TIMEFRAME OF WHEN THE DEVICE WAS WORN AND COULD POSSIBLY BE FROM ANOTHER PATIENT. DR. (B)(6) REQUESTED A NEW MONITOR BE PLACED ON THE PATIENT, SAME DAY, BUT FROM A DIFFERENT VENDOR. A ZIOPATCH FROM IRHYTHM WAS PLACED ON THE PATIENT. DR. (B)(6) CONFIRMED THAT THE BETA BLOCKER PRESCRIBED TO THE PATIENT SHOULD NOT BE TAKEN AND THE FAMILY CONFIRMED THEY HAD NOT FILLED THE PRESCRIPTION YET. (B)(6) 2025, DR. (B)(6) AND (B)(6) (PEDIATRIC STRESS LAB) CALLED (B)(6) FROM PREVENTICE AND SHARED THAT THE DEVICE THAT WAS PLACED ON OUR PATIENT ON (B)(6) 2025 HAD ERRONEOUS DATA AND PERHAPS WAS FROM THE PRIOR PATIENT THAT HAD WORN THE DEVICE. THE FINDINGS WERE ATRIAL TACHYCARDIA WHICH REQUIRE MEDICATION. (B)(6) SHARED HE WAS ESCALATING THIS TO HIS LEADERSHIP TEAM FOR INVESTIGATION. THE DIRECTOR OF THE PEDIATRIC STRESS LAB WAS NOTIFIED OF THIS INCIDENT ON (B)(6) 2025 AND SHE IMMEDIATELY CALLED (B)(6) RISK DEPARTMENT TO NOTIFY OF THIS INCIDENT AND TO REQUEST NEXT STEPS. RISK REQUESTED THAT SHE FILL OUT THIS EVENT AND SUBMIT. ADDITIONALLY, A UCSF INCIDENT REPORT HAS BEEN FILED REGARDING THE INCIDENT. DATES THAT WERE ANALYZED DID NOT MATCH DEPLOYMENT DATE (SEE INFORMATION ABOVE); ADDITIONAL MONITOR PLACED (B)(6) 2025 TO REPEAT ANALYZATION OF HEART RHYTHM.