BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 3051215 · Received April 10, 2013

    Report

    Report Number
    2182208-2013-01056
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 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

    EVALUATION SUMMARY: THE PROGRAMMER WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE STYLUS AND DISPLAY SCREEN WERE OUT OF ALIGNMENT IN SOME AREAS. ANALYSIS ALSO FOUND THAT THE SYSTEM FAN WAS NOISY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISPLAY SCREEN OF THE PROGRAMMER WAS WAY OUT OF ALIGNMENT WITH THE STYLUS. RECALIBRATION WAS ATTEMPTED A NUMBER OF TIMES BUT THE SITUATION WORSENED TO THE POINT OF THE PROGRAMMER BECOMING UNUSABLE. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISPLAY SCREEN OF THE PROGRAMMER WAS WAY OUT OF ALIGNMENT WITH THE STYLUS. RECALIBRATION WAS ATTEMPTED A NUMBER OF TIMES BUT THE SITUATION WORSENED TO THE POINT OF THE PROGRAMMER BECOMING UNUSABLE. 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
    151968 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MANUFACTURING 2090

    Patients

    Seq Age Sex Outcome Treatment
    1