BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952360 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00159
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 12, 2012
    Report Date
    December 14, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE 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).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE LIQUID CRYSTAL DISPLAY (LCD) WAS DAMAGED. ANALYSIS FOUND MISSING SEGMENTS IN THE LOWER DISPLAY, "BLEEDING" ON THE UPPER DISPLAY AND THAT A GASKET WAS OBSTRUCTING THE VIEW OF THE DISPLAY. ANALYSIS ALSO FOUND THAT THE MAIN PRINTED CIRCUIT BOARD WAS OUT OF SPECIFICATION ELECTRICALLY AND THAT THE UNIT FAILED BATTERY REMOVAL AMPLITUDE AND THE DEVICE SHUT OFF WHEN THE BATTERY WAS REMOVED, THE UPPER AND LOWER CASES BROKEN AND CONTAMINATED, SIDE BAIL COVERS, SIDE BAILS, RING COVER AND RING WERE MISSING, THE BATTERY CONTACTS WERE COMPRESSED, THE KEYBOARD HAD COSMETIC DAMAGE (IT WAS SCRATCHED), THE UNIT NEEDED A LCD SCREW AND BATTERY DRAWER O-RING. IT WAS FURTHER NOTED THAT DUE TO EXTENSIVE DAMAGE, THE GENERATOR WAS BEING RETURNED TO THE CUSTOMER UNREPAIRED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD A DAMAGED LIQUID CRYSTAL DISPLAY SCREEN. 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 HAD A DAMAGED LIQUID CRYSTAL DISPLAY SCREEN. 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
    55579 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1