BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 3051084 · Received April 10, 2013

    Report

    Report Number
    2182208-2013-01016
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THAT THE PROGRAMMER'S TOUCH PEN WAS OFF. TECHNICAL SUPPORT (TS) SHOWED THE CLINICIAN HOW TO CALIBRATE THE TOUCH PEN. THE TOUCH PEN WAS WORKING BETTER AFTER THE CALLER HAD UNPLUGGED AND PLUGGED THE TOUCH PEN BACK IN. THE DEVICE WAS RESTORED TO SERVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152317 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1