BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2951479 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00029
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    September 28, 2012
    Report Date
    November 16, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: (B)(4): ANALYSIS FOUND INTERMITTENT TELEMETRY AND THE UPLINK FUNCTIONAL TEST WAS OUT OF ELECTRICAL SPECIFICATION DUE TO THE CABLE. IT WAS ALSO NOTED THAT THE LABEL BACKING WAS MISSING, AND THE WINDOW LENS WAS CRACKED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER OCCASIONALLY STALLS DURING USE AND WOULD NOT RELIABLY INTERROGATE DEVICES. THE PROGRAMMER AND R ADIOFREQUENCY HEAD WERE RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56541 CARELINK PROGRAMMER, PACEMAKER KRG RICE CREEK MFG 2067

    Patients

    Seq Age Sex Outcome Treatment
    1