BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBD

    MDR report key: 2865024 · Received December 10, 2012

    Report

    Report Number
    2183613-2012-02052
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 15, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT. THE PRINTED CIRCUIT BOARD WAS REPLACED DUE TO NOISE ON THE ELECTROCARDIOGRAM (ECG). (B)(4).

    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)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER EXHIBITED NOISE ON THE ELECTROCARDIOGRAM (ECG)AND THAT A TEST FAILURE OCCURRED, GENERATING AN ERROR CODE (1012). THE PROGRAMMER WAS RETURNED FOR SERVICE. CALIBRATION AND TEST WERE REQUESTED AS WELL AS UPDATING THE PROGRAMMER'S HANDLE AND REPLACING THE LABEL ON THE PROGRAMMER HEAD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER EXHIBITED NOISE ON THE ELECTROCARDIOGRAM (ECG)AND THAT A TEST FAILURE OCCURRED, GENERATING AN ERROR CODE (1012). THE PROGRAMMER WAS RETURNED FOR SERVICE. CALIBRATION AND TEST WERE REQUESTED AS WELL AS UPDATING THE PROGRAMMER'S HANDLE AND REPLACING THE LABEL ON THE PROGRAMMER HEAD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TBD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC MILACA, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1