BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2951811 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00089
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, SO THE HARD DISK DRIVE WAS RECONFIGURED AND SOFTWARE WAS RELOADED. IT WAS ALSO CONFIRMED THAT THE PAPER SPEED BUTTONS ARE SLOW TO RESPOND, THE PRINTER KEYPAD ASSEMBLY WAS REPLACED, AND THE PATIENT CABLE CONNECTION WAS LOOSE, THE PRINTED CIRCUIT BOARD WAS REPLACED. IT WAS ALSO NOTED THAT BOTH KEYBOARD CASE HINGES WERE BROKEN. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS "VERY SLOW TO BOOT UP," AND THE CONNECTOR WAS LOOSE. ALSO NOTED, WAS THAT THE PRINTER SPEED BUTTONS DO NOT WORK. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57588 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067L RF HEAD