BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3151564 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01152
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RADIO FREQUENCY (RF) PROGRAMMER HEAD WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT, THERE WAS IN TERMITTENT TELEMETRY. THE PROGRAMMER HEAD CABLE WAS REPLACED AND THEN IT PASSED ALL FUNCTIONAL AND SYSTEMS TESTS. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: PRODUCT ID 2090 PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RADIO FREQUENCY PROGRAMMER HEAD HAD DIFFICULTY ESTABLISHING TELEMETRY. FOLLOW-UP DETERMINED THAT THE PROGRAMMER HEAD HAD BEEN CHANGED OUT IN ORDER TO ISOLATE THE ISSUE. THE PROGRAMMER HEAD WAS RETURNED FOR SERVICE. FOLLOW-UP ALSO INDICATED THAT THERE WAS NO IMPACT TO THE PATIENT AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RADIO FREQUENCY PROGRAMMER HEAD HAD DIFFICULTY ESTABLISHING TELEMETRY. FOLLOW-UP DETERMINED THAT THE PROGRAMMER HEAD HAD BEEN CHANGED OUT IN ORDER TO ISOLATE THE ISSUE. THE PROGRAMMER HEAD WAS RETURNED FOR SERVICE. FOLLOW-UP ALSO INDICATED THAT THERE WAS NO IMPACT TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252795 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MANUFACTURING 2067

    Patients

    Seq Age Sex Outcome Treatment
    1