BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3860249 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01502
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    February 12, 2014
    Report Date
    March 12, 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 FOUND THAT THE RIGHT SIDE OF KEYBOARD WAS STARTING TO COME APART, THE KEYBOARD WAS LOOSE BECAUSE IT WAS NOT INSERTED INTO THE HINGES, THE KEYBOARD SLIDE PLATE COVER WAS MISSING, THE SHIELDED GRILL ON THE FAN SIDE OF THE LOWER CASE WAS DAMAGED, THE LINK ELECTRONIC MODULE (LEM) CIRCUIT BOARD HAD A LOOSE ELECTROCARDIOGRAM (ECG) CONNECTOR. IT COULD NOT BE CONFIRMED THAT THE PROGRAMMER HAD A LONG BOOT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER IS SLOW TO BOOT UP AND THE KEYBOARD IS LOOSE. FOLLOWUP INFORMATION RECEIVED INDICATES CLINIC WHO USES THE PROGRAMMER REPORTED OVERALL SLUGGISHNESS WITH THE PROGRAMMER AT BOOT UP, THROUGHOUT USE AND IN SAVING TO PDF (PORTABLE DOCUMENT FORMAT). THE PROGRAMMER WAS RETURNED FOR REPAIR. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343246 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY (RF) HEAD