BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3151540 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00507
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    February 14, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE DISPLAY WAS OUT OF ELECTRICAL SPECIFICATION. IT WAS ALSO NOTED THAT THE UPPER CASE WAS BROKEN, THE LOWER CASE WAS BROKEN, THE BATTERY RELEASE WAS CONTAMINATED, TWO SIDE BAIL COVERS WERE BROKEN, THE LEAD FLEX COVER WAS CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, THE BATTERY DRAWER WAS CONTAMINATED, AND THE BATTERY FLEX WAS CONTAMINATED. (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER ANALYSIS WAS PERFORMED ON THE DISPLAY MODULE AND BATTERY FLEX. THIS ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT OR THE FAILURE FOUND DURING SERVICING OF THE DEVICE. NO DEFECT FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE MENU DISPLAY IS MISSING OR NOT WORKING. THE DEVICE 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
    252740 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1