BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYCARELINK

    MDR report key: 7484636 · Received May 3, 2018

    Report

    Report Number
    3004593495-2018-00467
    Event Type
    Malfunction
    Date Received
    May 3, 2018
    Date of Event
    April 3, 2018
    Report Date
    June 22, 2018
    Manufacturer
    PLEXUS MANUFACTURING SDN. BHD
    Product Code
    NVZ
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    BRAND NAME: MYCARELINK, MODEL #:24950, CATALOG #:24950, OPER OF DEV: LAY USER/PATIENT PMA / 510(K) #:P890003. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PINS OF THE POWER CORD WERE BROKEN. NO TROUBLESHOOTING TAKEN. THE MONITOR STATUS IS UNKNOWN. NO PATIENT COM PLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327387 MYCARELINK PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ PLEXUS MANUFACTURING SDN. BHD 24950

    Patients

    Seq Age Sex Outcome Treatment
    1