BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2952327 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00094
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 13, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS WAS ABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE DISPLAY WAS OUT OF SPECIFICATION. ANALYSIS ALSO FOUND THAT THE LOWER CASE AND BOTH BAIL COVERS WERE BROKEN AND RING IS BENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISPLAY ON THE EXTERNAL PULSE GENERATOR HAD PIXELS MISSING FROM THE LOWER RIGHT SIDE OF THE 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 DISPLAY ON THE EXTERNAL PULSE GENERATOR HAD PIXELS MISSING FROM THE LOWER RIGHT SIDE OF THE 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
    56921 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1