BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2813012 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01870
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 3, 2012
    Report Date
    November 27, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 CONFIRMED THE REPORTED EVENT, THE DISPLAY WAS OUT OF SPECIFICATION DUE TO INTERMITTENT MISSING PIXELS. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN, THE BATTERY RELEASE WAS CONTAMINATED, THE SIDE BAIL COVERS AND SIDE BAILS WERE MISSING, THREE CASE SCREWS WERE MISSING, THE LEAD FLEX COVER WAS CORRODED, THE BATTERY CONTACTS WERE COMPRESSED, THE SERIAL NUMBER LABEL WAS TORN, THE KEYBOARD WAS SCRATCHED AND THE BATTERY DRAWER O-RING WAS MISSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR'S LIQUID CRYSTAL DISPLAY (LCD) WAS DAMAGED, THAT SEGMENTS WERE MISSING IN THE GENERATOR'S LOWER DISPLAY. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THIS WAS FOUND DURING A ROUTINE CHECK OF THE DEVICE, SO THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BIOMED WAS DOING ROUTINE CHECKOUT OF DEVICE AND FOUND THAT THERE ARE MISSING SEGMENTS IN 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