BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYZER CABLE

    MDR report key: 4160982 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02761
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SOFTWARE ANALYZER CABLE HAD BENT PRONGS IN THE CONNECTOR. THE CABLE WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642487 ANALYZER CABLE PROGRAMMER, PACEMAKER KRG MEDTRONIC INC. 2292

    Patients

    Seq Age Sex Outcome Treatment
    1