BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3153687 · Received June 8, 2013

    Report

    Report Number
    2183613-2013-00620
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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) DISPLAYED A SELF-TEST ERROR MESSAGE WHEN POWERED ON. THE BIOMEDICAL ENGINEER (BE) RECEIVED THE EPG WITH THE ERROR MESSAGE DISPLAYED. THE ERROR CLEARED WHEN THE BATTERY WAS REMOVED AND REPLACED. THE BE WAS ABLE TO "FORCE" THE ERROR MESSAGE AND SUBSEQUENTLY CLEAR IT. THIS WAS COMPLETED "MULTIPLE TIMES" AND EACH TIME THE EPG POWERED UP WITHOUT ANY ISSUES. THE EPG WAS PLACED BACK INTO SERVICE AND REMAINS IN USE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256968 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1