BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2955134 · Received February 11, 2013

    Report

    Report Number
    2182208-2013-00264
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    November 21, 2012
    Manufacturer
    RICE CREEK MFG
    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

    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 DEVICE FAILED THE ELECTROMAGNETIC FIELD IMMUNITY TEST DUE TO THE CABLE BEING OUT OF ELECTRICAL SPECIFICATION. IT WAS ALSO NOTED THAT THE RUBBER COATING ON THE LABEL WAS ABSENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS OPENED AND A PROGRAMMER ERROR WAS NOTED. THE SERVICE DISK WAS RUN BUT THE ERROR WAS NOT ABLE TO BE CLEARED. THE PROGRAMMER AND RADIOFREQUENCY (RF) HEAD WERE RETURNED FOR SERVICE. BOTH PRODUCTS WERE ANALYZED AND TESTED OUT OF SPECIFICATION. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58875 CARELINK PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2067L

    Patients

    Seq Age Sex Outcome Treatment
    1