BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4163014 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-03029
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC, INC.
    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: ANALYSIS FOUND THE RF (RADIO FREQUENCY) HEAD OUT OF SPECIFICATION ON ELECTROMAGNETIC FIELD IMMUNITY TEST. A HOLE WAS FOUND IN THE RF (RADIO FREQUENCY) HEAD CABLE INSULATION, THE PROGRAM BUTTON IS BROKEN, LENS IS CLOUDY, THE LOWER CASE IS CRACKED, AND THE BACKING IS MISSING ON THE RF HEAD LABEL. (B)(4).

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THE BUTTONS ON THE TOP OF PROGRAMMER HEAD ARE BROKEN AND THE BACK LABEL PAD IS MISSING. THE PROGRAMMER HEAD WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639751 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2067L

    Patients

    Seq Age Sex Outcome Treatment
    1 2090 PROGRAMMER