BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2952708 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00222
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    RICE CREEK MANUFACTURING
    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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS FOUND THAT THE PROGRAMMER POWERS UP TO A BLANK SCREEN, THE LOW VOLTAGE DIFFERENTIAL SIGNALING (LVDS) BOARD WAS NOT FULLY SEATED. IT WAS ALSO NOTED THAT THE HINGE PLATE WAS MISSING SCREWS, THE HINGE PLATE WAS CRACKED, THE ELECTROCARDIOGRAM (ECG) CONNECTOR WAS LOOSE AND THE SYSTEM FAN WAS NOISY. PRODUCT ID 2067 RADIOFREQUENCY HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER BOOTED TO A BLACK SCREEN AND THAT IT REMAINED BLACK. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER BOOTED TO A BLACK SCREEN AND THAT IT REMAINED BLACK. THE PROGRAMMER AND RADIOFREQUENCY (RF) HEAD WERE RETURNED FOR SERVICE, ANALYZED AND TESTED OUT OF SPECIFICATION. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57256 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MANUFACTURING 2090

    Patients

    Seq Age Sex Outcome Treatment
    1