BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152337 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00678
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE LIQUID CRYSTAL DISPLAY (LCD) WAS MISSING SEGMENTS AND ANALYSIS DETERMINED THAT THE LCD GASKET WAS SEEPING OUT. ANALYSIS ALSO FOUND THAT THE UPPER AND LOWER CASES AS WELL AS ONE SIDE COVER WERE BROKEN, THAT ONE SIDE COVER AND ONE SIDE BAIL WERE MISSING, THE BATTERY CONTACTS WERE COMPRESSED, THE KEYBOARD PAD WAS CONTAMINATED (COSMETIC) AND THAT THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF SPECIFICATION/CONTAMINATED. IT WAS FURTHER NOTED THAT DUE TO EXTENSIVE DAMAGE THE GENERATOR WAS BEING RETURNED TO THE CUSTOMER UNREPAIRED. (B)(4).

    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).

    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'S LIQUID CRYSTAL DISPLAY (LCD) HAD SEGMENTS BLACKED OUT ON THE BOTTOM. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR'S LIQUID CRYSTAL DISPLAY (LCD) HAD SEGMENTS BLACKED OUT ON THE BOTTOM. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252896 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1