BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 4161036 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02755
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 16, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE DISPLAY WAS "BROKEN" IT WAS MISSING PIXELS, AND FURTHER NOTED THAT THE DISPLAY HAD BEEN TAMPERED WITH, THE METAL TABS WERE MOVED, THE SILICONE WAS MISSING ON THE CONNECTORS, THE KEYBOARD FLEX WAS INSERTED UNDER ITS CONNECTOR AND ONE SIDE OF A BOARD CONNECTOR WAS OPEN. ANALYSIS ALSO FOUND THAT THE UPPER CASE WAS DENTED, THE SIDE BAIL COVERS WERE BROKEN, THE RING COVER AND BATTERY DRAWER WERE CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, THE KEYBOARD WAS SCRATCHED AND THE ENCODER FLEX WAS TORN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISPLAY WAS BROKEN. THE EXTERNAL PULSE GENERATOR (EPG) HAS BEEN RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642412 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5388XS

    Patients

    Seq Age Sex Outcome Treatment
    1