BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3040854 · Received April 8, 2013

    Report

    Report Number
    2183613-2013-00219
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AND WILL NOT BE EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING DEVICE POWER UP THERE WAS AN ERROR CODE DISPLAYED. THE BATTERY WAS REMOVED FROM THE DEVICE AND THE ERROR WAS CLEARED. THE DEVICE WILL BE PLACED BACK INTO SERVICE. THERE WAS NO PATIENT INVOLVEMENT DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143765 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1