BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151837 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01238
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE RADIO FREQUENCY (RF) PROGRAMMER HEAD WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE RF HEAD WAS NOT WORKING, IT WAS ATTRIBUTED TO A CABLE WHICH WAS ELECTRICALLY OUT OF SPECIFICATION. THE CABLE WAS REPLACED AND THE PROGRAMMER HEAD PASSED ALL FUNCTIONAL AND SYSTEMS TESTS. (B)(4).

    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 PRODUCTS: PRODUCT ID 2090 PROGRAMMER. (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 WAS UNABLE TO COMPLETE ITS BOOT-UP/SELF-TEST, THAT IT STOPPED ON THE SCREEN WHICH DISPLAYS THE COMPANY LOGO. IT WAS FURTHER NOTED THAT THE RADIO FREQUENCY PROGRAMMER HEAD DID NOT WORK. THE PROGRAMMER AND THE PROGRAMMER HEAD WERE 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 WAS UNABLE TO COMPLETE ITS BOOT-UP/SELF-TEST, THAT IT STOPPED ON THE SCREEN WHICH DISPLAYS THE COMPANY LOGO. IT WAS FURTHER NOTED THAT THE RADIO FREQUENCY PROGRAMMER HEAD DID NOT WORK. THE PROGRAMMER AND THE PROGRAMMER HEAD WERE 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
    252747 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2067

    Patients

    Seq Age Sex Outcome Treatment
    1