BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2952148 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00129
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WOULD NOT POWER UP. THE CALLER TRIED OTHER CORDS. THE PROGRAMMER WILL BE RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55703 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1