BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3861831 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01746
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 14, 2014
    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

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE PROGRAMMER CANNOT SAVE TO DISK OR RETRIEVE FROM A DISK DUE TO THE METAL COVER FROM THE DISKETTE WAS STUCK IN THE FLOPPY DISK DRIVE. IT WAS ALSO NOTED THAT THE POWER SUPPLY AND SYSTEM FAN WERE NOISY, AND THE ELECTROCARDIOGRAM (ECG) CONNECTOR WAS LOOSE ON THE LINK ELECTRONIC MODULE (LEM) CIRCUIT BOARD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE FLOPPY DISK PORT IS BROKEN; CANNOT SAVE TO DISK OR RETRIEVE FROM A DISK. THE PROGRAMMER WAS RETURNED FOR REPAIR. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339713 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1