BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2953250 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00298
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 30, 2012
    Report Date
    December 30, 2012
    Manufacturer
    RICE CREEK MANUFACTURING
    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

    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 CONFIRMED THE REPORTED EVENT, THE PRINTED CIRCUIT BOARD WAS OUT OF ELECTRICAL SPECIFICATION. IT WAS ALSO NOTED THAT THE STYLUS TIP WAS SEPARATED FROM THE MAIN BODY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS HAVING TROUBLE "FINDING" IMPLANTED DEVICES. THE PROGRAMMER HEAD WAS CHANGED OUT TWO TIMESBUT THE SITUATION DID NOT RESOLVE. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56001 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MANUFACTURING 2090

    Patients

    Seq Age Sex Outcome Treatment
    1