BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2951817 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00091
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    RICE CREEK MANUFCTURING
    Product Code
    DXY
    PMA / PMN Number
    P890003/S080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; A PRINTED CIRCUIT BOARD WAS FOUND OUT OF ELECTRICAL SPECIFICATION AND PREVENTS PROGRAMMER FROM POWERING ON CORRECTLY. ANALYSIS ALSO FOUND THE SYSTEM FAN WAS NOISY AND THE STYLUS WAS MISSING.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER SWITCHED OFF DURING A CHECK AND WAS NOT ABLE TO BE TURNED ON AGAIN. 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
    57590 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MANUFCTURING 2090

    Patients

    Seq Age Sex Outcome Treatment
    1