BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3160320 · Received June 10, 2013

    Report

    Report Number
    2183613-2013-00783
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) POWERED ON WITH AN ERROR MESSAGE. THE BIOMEDICAL ENGINEER WAS ABLE TO CLEAR THE ERROR BY REMOVING THE BATTERY. THE POWER WAS SWITCHED ON AND OFF AND THEN OFF TO ON SEVERAL TIMES AND THE DEVICE POWERED ON TO THE DEFAULT SETTINGS WITH NO ERROR MESSAGE. TECHNICAL SUPPORT (TS) EXPLAINED TO THE BIOMEDICAL ENGINEER HOW THIS ERROR CAN OCCUR AND HOW TO CLEAR THE ERROR. THE DEVICE WAS RESTORED TO SERVICE AND WILL BE PLACED BACK INTO SERVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259775 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention