BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2377708 · Received December 15, 2011

    Report

    Report Number
    2182208-2011-03181
    Event Type
    Malfunction
    Date Received
    December 15, 2011
    Date of Event
    October 10, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P890003/S173
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE E-DEVICE CELLULAR ACCESSORY WAS HEATED AND SMOKE WAS COMING OUT OF THE DEVICE. THE PATIENT HAD TRIED TO SEND A TRANSMISSION TO THE HOSPITAL. THE E-DEVICE CELLULAR ACCESSORY WILL BE REPLACED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PATIENT MONITORING ACCESSORY NVZ MEDTRONIC, INC. MLINK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other