BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4162818 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-03050
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; ECG (ELECTROCARDIOGRAM) CONNECTOR IS LOOSE ON THE LEM (LINK ELECTRONIC MODULE) PRINTED CIRCUIT BOARD ASSEMBLY. ANALYSIS ALSO FOUND THE SYSTEM FAN IS NOISY, LATCH ON KEYBOARD IS BROKEN, LATCH TAB ON POWER CORD BAY DOOR IS BROKEN, AND THE FLOPPY DRIVE IS MISSING THE FRAME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE ECG (ELECTROCARDIOGRAM) SIGNAL WAS UNCLEAR. IT WAS SUSPECTED THE ECG INPORT PORT HAS A PROBLEM, IT WAS FOUND LOOSE. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639210 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1