BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2951476 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00028
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 16, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    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: ANALYSIS FOUND THAT THE CABLE INSULATION WAS CUT AND FUNCTIONALLY OUT OF SPECIFICATION DUE TO THE CABLE. IT WAS ALSO NOTED THAT THE LABEL BACKING WAS MISSING. (B)(4).

    Description of Event or Problem · 1

    THE RADIOFREQUENCY (RF) HEAD WAS 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
    56540 CARELINK PROGRAMMER, PACEMAKER KRG RICE CREEK MFG 2067

    Patients

    Seq Age Sex Outcome Treatment
    1