BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3152876 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01363
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCT: PRODUCT ID 2067 RADIO FREQUENCY PROGRAMMER HEAD. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED PHENOMENON OF ERROR MESSAGES GENERATED. THE LINK ELECTRONIC MODULE (LEM) WAS CALIBRATED, THE HARD DRIVE RECONFIGURED AND THE SOFTWARE RELOADED. ANALYSIS ALSO FOUND THAT THE SYSTEM FAN WAS NOISY AND IT WAS REPLACED. THE PROGRAMMER PASSED FUNCTIONAL AND SYSTEMS TESTS, NO OTHER ANOMALIES WERE FOUND. (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 UPON START UP OF THE PROGRAMMER IT GENERATED ERROR MESSAGES. FOLLOW-UP DETERMINED THAT THE PROGRAMMER WAS ABLE TO COMPLETE THE DEVICE CHECK PROPERLY. 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 UPON START UP OF THE PROGRAMMER IT GENERATED ERROR MESSAGES. FOLLOW-UP DETERMINED THAT THE PROGRAMMER WAS ABLE TO COMPLETE THE DEVICE CHECK PROPERLY. 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
    255134 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1