BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151852 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01232
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE RADIO FREQUENCY (RF) PROGRAMMER HEAD WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT IT DID NOT WORK. IT WAS UNABLE TO INTERROGATE AND ITS UPLINK FUNCTIONAL TESTS WERE OUT OF SPECIFICATION. THE PROGRAMMER HEAD'S CABLE WAS REPLACED AND THE HEAD THEN 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 2090AM PROGRAMMER; PRODUCT ID 229047 SOFTWARE ANALYZER. (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 RADIO FREQUENCY PROGRAMMER HEAD WAS NOT WORKING. THE PROGRAMMER HEAD WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTEDAS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER'S PRINTER WAS NOT WORKING. IT WAS FURTHER REPORTED THAT THE RADIO FREQUENCY PROGRAMMER HEAD WAS NOT WORKING. THE PROGRAMMER AND THE PROGRAMMER HEAD WERE RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTEDAS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253254 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MANUFACTURING 2067

    Patients

    Seq Age Sex Outcome Treatment
    1