BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952562 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00196
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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)(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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE DISPLAY WAS MISSING PIXELS. (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 THE BIOMED WAS DOING ROUTINE CHECKOUT OF DEVICE AND FOUND THAT ON THE RIGHT SIDE OF THE LOWER SCREEN ABOUT A QUARTER INCH IN FROM THE OUTER EDGE IT IS BLANK AND DOES NOT DISPLAY GRAPHICS. IT WAS ALSO REPORTED THE LOWER RIGHT SIDE OF THE MENU SCREEN IS MISSING PIXELS AND THERE ARE VERTICAL BLANK LINES/SPACE. THE DEVICE WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BIOMED WAS DOING ROUTINE CHECKOUT OF DEVICE AND FOUND THAT ON THE RIGHT SIDE OF THE LOWER SCREEN ABOUT A QUARTER INCH IN FROM THE OUTER EDGE IT IS BLANK AND DOES NOT DISPLAY GRAPHICS. IT WAS ALSO REPORTED THE LOWER RIGHT SIDE OF THE MENU SCREEN IS MISSING PIXELS AND THERE ARE VERTICAL BLANK LINES/SPACE. THE DEVICE WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57451 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP RICE CREEK MFG 5388

    Patients

    Seq Age Sex Outcome Treatment
    1