BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2951529 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00052
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 14, 2012
    Report Date
    November 14, 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 THE BLACK TOUCH PEN WAS "NOT GOOD", THAT IT OFTEN TOOK SEVERAL TOUCHES TO ACTIVATE THE PROGRAMMER. THE CALLER ALSO STATED THAT THEY WERE GETTING NOISE ON THE ELECTROCARDIOGRAM (ECG) IN THE NEW OFFICE. TECHNICAL SUPPORT (TS) ADVISED THE COMPANY REPRESENTATIVE TO MAKE SURE THAT THE ARTIFACT DETECTION WAS OFF AND ALSO SUGGESTED TO THE CALLER TO MAKE SURE THE FACILITY ELECTRICAL GROUNDS WERE GOOD. THE PROGRAMMER 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
    55572 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1