BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMONITOR 2-AF

    MDR report key: 19658434 · Received July 1, 2024

    Report

    Report Number
    MW5156914
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Report Date
    June 28, 2024
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MXD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE A LOOP RECORDER THAT WAS IMPLANTED IN (B)(6) 2018 (BIOMONITOR 2-AF BY BIOTRONIK). WHEN IT WAS INSERTED I HAD TO OBTAIN A LANDLINE DEVICE (CARDIOMESSENGER II-S TLINE) SO THAT DATA COULD BE DOWNLOADED AND TRANSMITTED NIGHTLY TO MY CARDIOLOGIST BECAUSE THE CELL DEVICE (CARDIOMESSENGER SMART) WOULD NOT WORK AT MY HOME DUE TO NO CELL SERVICE COVERAGE IN THE RURAL AREA WHERE I LIVE. THIS IS HOW DATA HAS BEEN SENT SINCE THAT TIME UP UNTIL 3 WEEKS AGO WHEN SUDDENLY MY LANDLINE PHONE STARTED RINGING FUNNY AND I COULD HEAR A DIAL-UP SOUND WHEN TALKING ON THE PHONE. ONE DAY I PICKED UP THE PHONE TO MAKE A CALL AND THERE WAS A VOICE MESSAGE ON THE LINE SAYING TO CALL BIOTRONIK BECAUSE THIS NUMBER WAS NO LONGER IN SERVICE AT 1-800-547-0394. I CALLED AND THEY TOLD ME THAT THEY HAD DISCONNECTED THEIR LANDLINE CAPABILITY AND ONLY HAD AN OPTION FOR CELL TRANSMISSIONS NOW. I WAS NOT NOTIFIED OF THIS IN ADVANCE AND WHEN CONSULTING WITH CARDIOLOGY THEY HAD NO TRANSMISSIONS IN APPROXIMATELY 8-10 DAYS. I EXPLAINED TO BIOTRONIK THAT WE DO NOT HAVE CELL SERVICE IN MY AREA AND THAT MY INSURANCE PAYS MONTHLY FOR THIS NIGHTLY MONITORING WHICH IS WHAT WE WERE PROMISED WHEN WE PAID TO HAVE THE DEVICE IMPLANTED. THEY SAID THEY WOULD SEND AN UPGRADED 4G DEVICE WHICH THEY DID AND THIS ALSO DID NOT WORK, WILL NOT TRANSMIT. THEY SIMPLY SAID THERE ARE NO OPTIONS EXCEPT FOR ME TO TAKE THE NEW DEVICE TO CELL SERVICE AREA FOR DOWNLOAD. THIS DEVICE HAS BEEN THE ONLY WAY THAT I HAVE KNOWN WHEN I AM HAVING PROBLEMS IN THE PAST AND I DO NOT GO INTO CELL PHONE SERVED AREAS EVERY DAY. IT WOULD SEEM TO ME THAT I AM NOT THE ONLY ONE IN THE WORLD WHO LIVES OUTSIDE OF CELL COVERAGE AND THAT THIS COMPANY, WHO GOT PAID A LOT FOR THIS DEVICE, IS NOW SHIRKING ITS RESPONSIBILITIES TO PATIENTS WHOM THEY PROMISED TO SERVE. THIS ALSO PUTS ME AT RISK FOR COMPLICATIONS THAT WILL GO UNDETECTED WHEN I CAN'T TRANSMIT WHICH WAS THE PURPOSE OF THE DEVICE IN THE FIRST PLACE. I DON'T SEE HOW A MEDICAL DEVICE COMPANY CAN DECIDE TO STOP PROVIDING A SERVICE THAT THEY HAVE PROVIDED FOR 6 YEARS TO A PATIENT WITH NO REAL PLAN IN PLACE OTHER THAN "YOU ARE GOING TO HAVE TO TRAVEL TO CELL SERVICE AREA AND TAKE THE DEVICE FOR IT TO DOWNLOAD." I PERSONALLY FIND THIS UNACCEPTABLE. REFERENCE REPORT: MW5156913.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472872 BIOMONITOR 2-AF RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITH ARRHYTHMIA DETECTION) MXD BIOTRONIK SE & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male AMOVIG 140 MG SQ MONTHLY.| ASPIRIN 325 MG ORAL DAILY.| CINNAMON 1,000 MG DAILY.| LEVOTHYROXINE 50 MCG DAILY.| MAGNESIUM 250 MG DAILY.| METFORMIN 500 MG DAILY.| MONTELUKAST 10 MG DAILY.| NURTEC ODT 75 MG ORAL DAILY AS NEEDED FOR MIGRAINE.| PANTOPRAZOLE 40 MG DAILY.| PRAMIPEXOLE 0.25 MG 1/2 TAB DAILY.| SERTRALINE 25 MG DAILY.| TYLENOL 500 MG EVERY 6 HRS PRN PAIN.| VIAGRA 50 MG DAILY AS NEEDED.| VITAMIN B12 1,000 MG DAILY.| VITAMIN D3 2,000 UNITS DAILY.