BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3991120 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-01003
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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) DISPLAYED AN ERROR CODE DURING A SELF TEST. TECHNICAL SUPPORT (TS) EXPLAINED THAT IT WAS LIKELY DUE TO A DEPRESSED KEY OR SOMEONE PRESSING THE PAUSE KEY DURING THE TEST. TS RECOMMENDED REMOVING BATTERY TO RESET EPG AND TURN ON DEVICE AGAIN. THE EPG IS WORKING AS DESIGNED AND REMAINS IN USE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468708 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1