BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3152915 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01371
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    February 26, 2013
    Report Date
    April 13, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED ERROR MESSAGE. THE PROGRAMMER ERROR LOGS CONTAINED SYSTEM ERROR MESSAGES. SOFTWARE WAS RELOADED AND UPDATED. DURING CALIBRATION, TESTING FOUND THE PRINTED CIRCUIT BOARD TO BE OUT OF ELECTRICAL SPECIFICATION. THE POWER CORD BAY DOOR WAS ALSO OBSERVED TO BE BROKEN. PRODUCT ID 2067 PROGRAMMER RF (RADIO-FREQUENCY) HEAD, PRODUCT ID 2290 PACING SYSTEM ANALYZER. (B)(4)..

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ERROR MESSAGE OCCURRED. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS SUBSEQUENTLY RECEIVED THAT THE ERROR OCCURRED WHEN THE PROGRAMMER WAS STARTED UP. THE PROGRAMMER WAS REBOOTED, AND THE DEVICE CHECK WAS ABLE TO BE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254744 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1