BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2951799 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00099
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003/S080
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT THERE WAS NOISE ON THE PROGRAMMER/ANALYZER ELECTROCARDIOGRAM (ECG) DURING A CASE. THE CALLER DID CHANGE OUT THE CABLES AND ANALYZER, BUT THE NOISE WAS STILL VISIBLE. AS THE PROGRAMMER WAS PLUGGED INTO AN OUTLET STRIP, TECHNICAL SUPPORT (TS) NOTED THAT AT TIMES THE GROUNDS ON OUTLET STRIPS ARE POOR, WHICH WOULD CAUSE NOISE ON THE ECGS. THE COMPANY REPRESENTATIVE WILL TRY CONNECTING THE PROGRAMMER TO THE WALL OUTLET TO SEE IF THAT CHANGES THE NOISE CONDITION. THE PROGRAMMER REMAINS IN USE. FOLLOW-UP VERIFIED THAT THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57604 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1