BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3152764 · Received June 8, 2013

    Report

    Report Number
    6000031-2013-00003
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    TRIVIRIX MINNEAPOLIS
    Product Code
    NVZ
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE PREVIOUSLY WORKING REMOTE MONITOR WOULD NOT TURN ON. THE PATIENT REPLACED THE BATTERIES WITH NEW ONES AND IT STILL WOULD NOT WORK. THE PATIENT WAS ASKED TO RUN THE MONITOR OVER AND CHECK THE BATTERIES. THE PATIENT STATED THAT THE BLACK LIQUID CAME OUT OF THE BATTERY COMPARTMENT AND IT WAS ALSO ALL OVER THE BATTERIES. THE PATIENT WAS ADVISED TO REMOVE THE BATTERIES AND NOT USE THEM. THE PATIENT WAS REFERRED TO THE CLINIC FOR A REPLACEMENT AND IS RETURNING THE MONITOR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257453 CARELINK PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ TRIVIRIX MINNEAPOLIS 2490H

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR