BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2812292 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01845
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 20, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    PRODUCT EVENT SUMMARY EVALUATION SUMMARY (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE LIQUID CRYSTAL DISPLAY (LCD) WAS OUT OF SPECIFICATION, THAT IT WAS MISSING SEGMENTS. ANALYSIS ALSO FOUND THE UPPER AND LOWER CASES BROKEN, THE BATTERY CONTACTS COMPRESSED, THE RING AND ONE SIDE BAIL WERE BENT AND THE BATTERY DRAWER WAS BROKEN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE CHECK OF THE EPG (EXTERNAL PULSE GENERATOR), THE BIOMEDICAL ENGINEER FOUND THAT THERE WERE SEGMENTS MISSING ON THE LOWER DISPLAY. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE CHECK OF THE EPG (EXTERNAL PULSE GENERATOR), THE BIOMEDICAL ENGINEER FOUND THAT THERE WERE SEGMENTS MISSING ON THE LOWER DISPLAY. THE EPG 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 THE DEVICE AND FOUND THAT THERE ARE SEGMENTS MISSING ON THE LOWER DISPLAY. THE DEVICE IS BEING 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