BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3862249 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01701
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 1, 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 KEYBOARD WAS MISSING SCREWS AND WAS PULLING APART. IT WAS ALSO NOTED THAT THE ELECTROCARDIOGRAM (ECG) HAD CRACKED SOLDER JOINTS AND THE SCREEN WOULD NOT STAY IN PLACE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYBOARD DOOR WAS BROKEN, AND THE PROGRAMMER RF (RADIO-FREQUENCY) HEAD PAD WAS GONE. THE PROGRAMMER AND RF HEAD WERE RETURNED FOR REPAIR AND TEST/CALIBRATION. THE PROGRAMMER WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343342 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

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