BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2951624 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00048
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    October 31, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC MILACA INC
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY EVALUATION SUMMARY (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE LIQUID CRYSTAL DISPLAY (LCD) WAS MISSING SEGMENTS. ANALYSIS ALSO FOUND THAT THE LOWER CASE WAS BROKEN AND THAT THE UPPER CASE WAS DENTED, BOTH BAILS AND BOTH BAIL COVERS AND THE SIX CASE SCREWS WERE MISSING, THE RING COVER WAS BROKEN AND THE BATTERY CONTACTS WERE COMPRESSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISPLAY OF THE EXTERNAL PULSE GENERATOR (EPG) IS MISSING A LINE OF SEGMENTS AT THE A-V INTERVAL MILLISECOND MEASUREMENT. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISPLAY OF THE EXTERNAL PULSE GENERATOR (EPG) IS MISSING A LINE OF SEGMENTS AT THE A-V INTERVAL MILLISECOND MEASUREMENT. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISPLAY OF THE EXTERNAL PULSE GENERATOR (EPG) IS MISSING A LINE OF SEGMENTS AT THE A-V INTERVAL MILLISECOND MEASUREMENT. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57631 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA INC 5388

    Patients

    Seq Age Sex Outcome Treatment
    1