BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3153669 · Received June 8, 2013

    Report

    Report Number
    2183613-2013-00617
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) LOCKED AND DISPLAYED AN ERROR MESSAGE WHEN THE BIOMEDICAL ENGINEER (BE) PUSHED "OFF" TWICE. THE BE HAD INDICATED THAT THE EPG WAS REPORTED TO NOT BE "WORKING RIGHT" AND WAS GIVEN TO THE BE FOR TESTING. THE BE TOOK THE BATTERY OUT AND PLACED IT BACK IN. THE "ON" BUTTON WAS PUSHED AND THE ERROR CLEARED. THE BE COMPLETED THE PERIODIC MAINTENANCE CHECK AND THE EPG PASSED. THE EPG WILL BE TESTED ONCE AGAIN AND WILL BE PLACED BACK IN SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256455 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1