BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2813462 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01890
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Report Date
    December 14, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT, HOWEVER THE DISPLAY WAS OUT OF SPECIFICATION DUE TO MISSING SEGMENTS ON LOWER MENU. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN, THE RING COVER AND TWO SIDE BAIL COVERS WERE BROKEN, THE BATTERY RELEASE AND LEAD FLEX COVER WERE CONTAMINATED, THE RING AND TWO SIDE BAILS WERE MISSING, ONE BOARD CONNECTOR WAS OUT OF SPECIFICATION AND THE BATTERY DRAWER WAS BROKEN.

    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 FURTHER REPORTED THE MENU WILL NOT LIGHT UP; JUST FLASHING NOISE AT TURN ON, THEN BLANK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIQUID CRYSTAL DISPLAY (LCD) MENU ON THE EXTERNAL PULSE GENERATOR (EPG) WOULD NOT BOOT. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT. IT WAS FURTHER REPORTED THE MENU WILL NOT LIGHT UP; JUST FLASHING NOISE AT TURN ON, THEN BLANK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIQUID CRYSTAL DISPLAY (LCD) MENU ON THE EXTERNAL PULSE GENERATOR (EPG) WOULD NOT BOOT. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other