BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYCARELINK

    MDR report key: 7607150 · Received June 15, 2018

    Report

    Report Number
    3004593495-2018-00562
    Event Type
    Malfunction
    Date Received
    June 15, 2018
    Date of Event
    May 2, 2018
    Report Date
    July 12, 2018
    Manufacturer
    PLEXUS MANUFACTURING SDN. BHD
    Product Code
    NVZ
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: MYCARELINK MODEL #: 24950 CATALOG #: 24950 UNIQUE IDENTIFIER (UDI) #: ASKU PMA / 510(K) #: P890003. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SIGNIFICANT OTHER WAS BRINGING THE MODULE TO THE PATIENT'S CHEST TO UPLOAD THE DATA ON THE CLOUD, THE MODULE WAS TAKING TOO MUCH TIME BECAUSE THE PROGRESS BAR WAS MOVING SLOWLY. THE PROCESS TOOK TWO MINUTES TO REACH SEVENTY PERCENT. IT WAS ALSO REPORTED THAT THE PATIENT SAID "AH, IT IS BURNING ME, TAKE IT OFF ME". THE SIGNIFICANT OTHER TOOK THE MODULE AWAY FROM THE PATIENT AND THE COMMUNICATION WAS LOST. THE SIGNIFICANT OTHER WAITED A WHILE AND TRIED AGAIN. APPARENTLY, THE LINK WAS NO LONGER WORKING AND IT GAVE UP. THE NEXT DAY, THE PATIENT TRIED AGAIN AND THE LINK WORKED SATISFACTORILY. THE MONITOR REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447693 MYCARELINK PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ PLEXUS MANUFACTURING SDN. BHD 24950

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR