BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151946 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01212
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE NOISY ECG DUE TO THE CONNECTOR ON THE LINK ELECTRONIC MODULE (LEM) CIRCUIT BOARD BEING LOOSE. AS A RESULT THE LEM BOARD WAS REPLACED AND CALIBRATED. IT WAS ALSO CONFIRMED THAT THE TABS ON THE POWER CORD BAY DOOR WERE BROKEN AND THE MONITOR HINGE WAS LOOSE DUE TO MISSING HINGE PLATE SCREWS. IT WAS ALSO NOTED THAT THE FAN WAS NOISY.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 2067 PROGRAMMER RF (RADIO-FREQUENCY) HEAD. 2290 PACING SYSTEM ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE ELECTROCARDIOGRAM (ECG) HAS 60 CYCLE NOISE, AND THE PORT APPEARS TO HAVE BEEN DAMAGED. THE MONITOR HINGE AND CORD COMPARTMENT DOOR ARE ALSO DAMAGED. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252396 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1