BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2951625 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00049
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. EVALUATION SUMMARY (B)(4): THE DEVICE WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE LIQUID CRYSTAL DISPLAY (LCD) WAS BROKEN. ANALYSIS ALSO FOUND THAT THE UPPER CASE WAS BROKEN. (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISPLAY ON THE EXTERNAL PULSE GENERATOR (EPG) IS BROKEN. THE BIOMEDICAL ENGINEER STATED THAT IT IS LIKE THERE IS "BLACK INK RUNNING THROUGH IT." THE BIOMEDICAL ENGINEER ALSO NOTED THAT THE DEVICE MAY HAVE BEEN DROPPED. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55708 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1