BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3405053 · Received October 10, 2013

    Report

    Report Number
    2183613-2013-01374
    Event Type
    Injury
    Date Received
    October 10, 2013
    Date of Event
    July 17, 2013
    Report Date
    July 17, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 USER COULD NOT READ THE LOWER SCREEN OF THE EXTERNAL PULSE GENERATOR (EPG) AND THE DEVICE WAS NOT CAPTURING. THE BIOMEDICAL ENGINEER TESTED ALL FUNCTIONED WITH A SIGMA PACE 1000 WITH NO DIFFICULTY AND HAD NO PROBLEM READING THE LOWER LIQUID CRYSTAL (LCD) DISPLAY. THE BIOMEDICAL ENGINEER FELT IT WAS THE USER AND NOT THE DEVICE. TESTING SHOWED THE DEVICE OPERATING AS DESIGNED AND THE ISSUE OF CAPTURE COULD NOT BE DUPLICATED. EPG WORKING AS DESIGNED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518489 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention