BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3992849 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-01095
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 THE MONITOR WOULD NOT TRANSMIT AFTER TWO ATTEMPTS. IT WAS ALSO REPORTED THE MONITOR SMELLED HOT AND SHUT DOWN. THE MONITOR WAS REPLACED AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469436 CARELINK PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MILACA, INC. 2490H

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR