BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2952516 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00188
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    RICE CREEK MFG
    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE PROGRAMMER WOULD NOT POWER UP DUE TO THE PRINTED CIRCUIT BOARD BEING OUT OF ELECTRICAL SPECIFICATION. (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 THE PROGRAMMER WILL NOT BOOT UP. IT WAS ALSO REPORTED THE PROGRAMMER WILL NOT BOOT TO THE MAIN (MODEL SELECT) SCREEN. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER WILL NOT BOOT UP. IT WAS ALSO REPORTED THE PROGRAMMER WILL NOT BOOT TO THE MAIN (MODEL SELECT) SCREEN. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57183 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1