BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2812850 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03818
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 15, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P890003/S145
    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. EVALUATION SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT. THE STYLUS CALIBRATION WAS OFF AND COULD NOT BE CALIBRATED. THE OVERLAY BEZEL ASSEMBLY WAS REPLACED. THE POWER CORD BAY TAB WAS ALSO BROKEN OFF, AND THE PROGRAMMER CASE HANDLE WAS DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPANY REPRESENTATIVE HAD RECALIBRATED THE PROGRAMMER'S TOUCH PEN SEVERAL TIMES BUT WAS UNABLE TO GET THE PEN TO ACTIVATE ICONS PROPERLY, AS THE CALIBRATION WAS "WAY OFF" IN SOME AREAS. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PROGRAMMER NVZ MEDTRONIC, INC. 2090X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 2067L PROGRAMMER RF HEAD