BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3862042 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01725
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 8, 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 WAS UNABLE TO CONFIRM THE ERRORS, THE PROGRAMMER POWERED UP AND INTERROGATED WITH NO ERRORS. IT WAS NOTED THAT THERE WAS AN ERROR AFTER COMPLETING INTERROGATION AND PRINTING, THE ELECTROCARDIOGRAM (ECG) CONNECTOR WAS LOOSE ON THE LINK ELECTRONIC MODULE (LEM) CIRCUIT BOARD, THE TABS ON THE POWER CORD BAY DOOR WERE BROKEN, THE KEYBOARD HINGES WERE BROKEN AND THE SYSTEM FAN WAS NOISY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN ATTEMPTING TO UPDATE THE PROGRAMMER WITH USB (UNIVERSAL SERIAL BUS) STICK OR SDN (SOFTWARE DISTRIBUTION NETWORK), AN ERROR MESSAGE OCCURRED. THE PROGRAMMER WAS RETURNED FOR REPAIR. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343126 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

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