BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2953083 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00280
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 9, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE PRINTED CIRCUIT BOARD WAS REPLACED AND THE PROGRAMMER WAS UPDATED. PRODUCT ID 2067 RADIOFREQUENCY HEAD; PRODUCT ID 229047 ANALYZER.

    Description of Event or Problem · 1

    THE PROGRAMMER WAS RETURNED FOR REPAIR AND CALIBRATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PATIENT FOLLOW UP, THE DISPLAY OF THE PROGRAMMER "SUDDENLY" WENT BLACK. AFTER SWITCHING THE ON/OFF BUTTON, THE PROGRAMMER DID NOT HAVE POWER OR START UP. ANOTHER PROGRAMMER WAS USED WITHOUT ISSUE. THE STATUS OF THE PROGRAMMER IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55530 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR 2067 RF HEAD 2290 ANALYZER