BIOTEL EVENT MONITOR
Received Jan 2, 2025 · Event occurred Apr 26, 2022
Report MW5164264 · MDR key 21071458
Device
Generic name
Electrocardiograph, Ambulatory (without Analysis)
Manufacturer
Philips North America Llc.Patient
42 YR · Female
- Syncope/Fainting
- Unspecified Heart Problem
- Syncope/Fainting
- Unspecified Heart Problem
Narrative
Description of Event or Problem
I WAS WEARING A PHILLIPS BIOTEL EVENT MONITOR AFTER I HAD A SYNCOPE EVENT AT WORK. I HAD THE MONITOR ON AND HAD ANOTHER EVENT THE NEXT MORNING WHILE STILL WEARING THE MONITOR, I HAD A SYNCOPAL EVENT WHILE DRIVING MY CAR. I PASSED OUT FOR SECOND AND CAME TO SLOWLY ROLLING DOWN THE SIDE OF THE ROAD. I WENT TO THE ER AND WHEN THE PHILIPS BIOTEL MONITOR WAS INTERROGATED IT WAS REPORTED THAT NO EVENTS SHOWED UP ON THE MONITOR. RECEIVING THIS INFORMATION, IT WAS ASSUMED I MUST HAVE HAD SOME TYPE OF NEURO/SEIZURE EVENT AND MY CARE WAS THEN REFERRED TO NEUROLOGY. I HAD A CLEAR WORK UP NORMAL EEG(ELECTROENCEPHALOGRAM) AND BRAIN MRI FROM NEUROLOGY AND IT HAD BEEN 6 WEEKS SINCE MY SYNCOPE. 2 WEEKS LATER I PASSED OUT AGAIN, THANKFULLY WAS ONLY BRUISED UP, AND DIDN'T SUFFER A HEAD INJURY OR WORSE. AFTER ANOTHER ER VISIT, IT WAS DECIDE TO PUT ANOTHER EVENT MONITOR ON ME FOR 30 DAYS. AFTER ABOUT 3 WEEKS, I HAD ANOTHER SYNCOPE EVENT AND BIOTEL CALLED TO SAY I HAD A 17 SECOND CARDIAC PAUSE AND NEEDED TO GO TO THE ER. I WAS IN THE HOSPITAL FOR SEVERAL DAYS AND EVENTUALLY RECEIVED A PACEMAKER. WITH THE FAULTY PHILLIPS BIOTEL MONITOR BACK IN APRIL, IT DELAYED PROPER CARE BY 10 WEEKS, AND KNOWING THAT I HAD A 17 SECOND CARDIAC PAUSE, FOR ALL THOSE WEEKS I WAS HAD HIGH RISK TO MYSELF, DAUGHTER TO CAUSE TERRIBLE INJURY OR EVEN SUDDEN UNEXPLAINED DEATH, ADDED IN THE ADDITIONAL COST OF MEDICAL WORK UP, ADDITIONAL ER VISITS. IT IS RIDICULOUS FOR THE COST OF WEARING THAT MONITOR FOR 24 HOURS AND IT NOT PICKING UP EVENT I HAD WHILE DRIVING COMPLETELY SHOWS HOW DEFECTIVE THAT MONITOR WAS. IT WAS ABOUT 7:45 AM THAT I PASSED OUT WHILE WEARING THE DEVICE. I WAS TAKEN TO THE ER AND HAD A OVERNIGHT STAY IN THE HOSPITAL.