BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2133924 · Received June 20, 2011

    Report

    Report Number
    2183613-2011-00180
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    NVZ
    PMA / PMN Number
    P890003/S102
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN UNABLE TO COMPLETE A REMOTE MONITORING TRANSMISSION SINCE CHANGING RESIDENCES. THE DISPOSITION OF THE MONITOR IS UNCLEAR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PATIENT MONITORING INSTRUMENT NVZ MEDTRONIC MILACA INC. 2490C ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD| 5568 IMPLANTABLE PACING LEAD