BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3991486 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02141
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS WAS UNABLE TO REPLICATE THE CUSTOMER EXPERIENCE OF AN ERROR BUT THE HARD DRIVE WAS RECONFIGURED AND THE SOFTWARE RELOADED AS A PREVENTIVE. ANALYSIS DID FIND THAT THE ELECTROCARDIOGRAM (ECG) CONNECTOR ON THE LINK ELECTRONIC MODULE (LEM) BOARD WAS LOOSE AND THE BOARD WAS REPLACED AND CALIBRATED, AND THAT THE SYSTEM FAN WAS NOISY, THE UPPER CASE HAD A CRACKED HANDLE AND THE STYLUS WAS MISSING AND ALL WERE REPLACED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER HAD ERROR CODES APPEARING AT BOOT UP, AND DURING USE. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER HAD ERROR CODES APPEARING AT BOOT UP, AND DURING USE. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470302 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY PROGRAMMER HEAD