BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3992190 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-01119
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 BIOMEDICAL ENGINEER (BE) STATED THAT AN EXTERNAL PULSE GENERATOR (EPG) HAD A SELF-TEST ERROR. TECHNICAL SERVICES (TS) PROVIDED ASSISTANCE IN RESOLVING THE ISSUE BY EXPLAINING THE REASON FOR THE ERROR MESSAGE AND HAD THE BE REMOVE AND REINSERT THE BATTERY AND TURN THE EPG ON. THE BE COULD NOT DUPLICATE THE ERROR. THE EPG WAS PLACED BACK INTO SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470711 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1