BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 3151527 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01159
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    March 13, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THAT THE DEVICE POWERS UP WITH A DARK DISPLAY, THE DISPLAY WAS REPLACED. IT WAS ALSO NOTED THAT THE SYSTEM FAN WAS NOISY, THE KEYBOARD WAS MISSING SCREWS AND COMING APART, THE DISPLAY DROPS AND THE ELECTROCARDIOGRAM (ECG) CONNECTOR WAS LOOSE. CONCOMITANT PRODUCTS: PRODUCT ID 2067 RADIOFREQUENCY HEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER SCREEN WAS DARK AND THAT IT DID NOT ILLUMINATE CORRECTLY. THE PROGRAMMER WAS 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
    252194 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090AA

    Patients

    Seq Age Sex Outcome Treatment
    1