BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK SYSTEM

    MDR report key: 4831662 · Received June 10, 2015

    Report

    Report Number
    2182208-2015-01611
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 1, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THAT THE REMOTE MONITORING SERVICE WEBSITE WAS DISPLAYING INCORRECT DATA. THE WEBSITE REMAINS IN USE. NO PATIENT COM PLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374271 CARELINK SYSTEM DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. CARELINK

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR