BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3153365 · Received June 8, 2013

    Report

    Report Number
    2183613-2013-00607
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE LIQUID CRYSTAL DISPLAY (LCD) HAD MISSING PIXELS. ANALYSIS ALSO FOUND THAT THE ENCODER FLEX WAS OUT OF SPECIFICATION BUT IT APPEARED THAT THERE HAD BEEN A DISASSEMBLY AND REASSEMBLY PRIOR TO THE UNIT BEING RETURNED FOR SERVICING. ONE SIDE BAIL COVER AND RING COVER WERE BROKEN AND THE BATTERY CONTACTS WERE COMPRESSED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD MISSING SEGMENTS FROM THE LOWER LIQUID CRYSTAL DISPLAY (LCD) AND THAT IT WAS UNREADABLE. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NOT PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD MISSING SEGMENTS FROM THE LOWER LIQUID CRYSTAL DISPLAY (LCD) AND THAT IT WAS UNREADABLE. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NOT PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258195 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1