BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4832284 · Received June 10, 2015

    Report

    Report Number
    2182208-2015-01506
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 10, 2015
    Report Date
    March 10, 2015
    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED ECG (ELECTROCARDIOGRAM) PORT ISSUE; ECG CONNECTOR FOUND LOOSE ON THE LEM (LINK ELECTRONIC MODULE) PRINTED CIRCUIT BOARD ASSEMBLY. ANALYSIS ALSO CONFIRMED THE REPORTED KEYBOARD ISSUE; KEY (LETTER X) WAS MISSING ON THE KEYBOARD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE KEYBOARD IS BROKEN AND THE ECG (ELECTROCARDIOGRAM) PORT IS BROKEN. THE PROGRAMMER WAS RETURNED FOR THOROUGH EXAM AND REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376216 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 2067L RADIO FREQUENCY HEAD