BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2964656 · Received February 15, 2013

    Report

    Report Number
    2182208-2013-00429
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    November 17, 2012
    Report Date
    November 17, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 HINGE PLATE WAS LOOSE, HINGE PLATE SCREWS WERE MISSING, AND THE STYLUS WAS MISSING. UNABLE TO CONFIRM REPORTED EVENT. PRODUCT ID 229047 ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS RETURNED FOR REPAIR. FOLLOWUP INDICATES THE PROGRAMMER WAS NOT WORKING WHEN ATTEMPTING TO USE IT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66389 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1