BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3993567 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-01072
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 EXTERNAL PULSE GENERATOR (EPG) POWERED UP WITH A SELF-TEST ERROR. TECHNICAL SERVICES (TS) PROVIDED ASSISTANCE IN RESOLVING THE ISSUE BY EXPLAINING THE REASON FOR THE ERROR MESSAGE. TS SUGGESTED REMOVING THE BATTERY AND REINSERTING IT TO RESET THE EPG. THE ERROR COULD NOT BE DUPLICATED. THE EPG WAS RESTORED TO SERVICE AND REMAINS IN USE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472427 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1