BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151910 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01221
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 12, 2013
    Report Date
    June 14, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED SOFTWARE LOAD ISSUE. ANALYSIS FOUND THE ECG (ELECTROCARDIOGRAM) CONNECTOR OF A PRINTED CIRCUIT BOARD ASSEMBLY WAS LOOSE.

    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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTROCARDIOGRAM (ECG) ON THE PROGRAMMER WAS NOISY AND WAS HARD TO READ. IT WAS ALSO REPORTED THE ECG PORT IS DAMAGED. IT WAS NOTED THE PROGRAMMER WILL NOT COMPLETE INSTALLATION OF THE MOST CURRENT SOFTWARE FROM BOTH THE USB (UNIVERSAL SERIAL BUS) AND MEDTRONIC SERVER. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253287 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1