BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3152749 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01322
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003
    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. CONCOMITANT PRODUCTS: PRODUCT ID 2290 PACING SYSTEM ANALYZER, PRODUCT ID 2067L PROGRAMMER RF (RADIO-FREQUENCY) HEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE HARD DISK DRIVE WAS REIMAGED AND CURRENT SOFTWARE WAS RELOADED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN STAFF TURNED ON THE PROGRAMMER, THE SCREEN WOULD NOT BOOT UP; IT REMAINED GREY. THE SERVICE DISK WAS USED, WITH NO SUCCESS. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257470 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1