BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3153123 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01395
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    January 4, 2013
    Report Date
    March 19, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY 2067L: THE RADIO FREQUENCY PROGRAMMER HEAD WAS RETURNED AND ANALYSIS FOUND THAT ITS UPLINK AMPLITUDE WAS OUT OF SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER HAD A BROKEN SCREEN. IT WAS ALSO REQUESTED THAT THE PROGRAMMER BE UPDATED WITH THE LATEST VERSION OF SOFTWARE AND THAT IT RECEIVE ITS TEST AND CALIBRATION. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE RADIO FREQUENCY PROGRAMMER HEAD WAS RETURNED WITH NO INFORMATION AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255989 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2067L

    Patients

    Seq Age Sex Outcome Treatment
    1