BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 7182396 · Received January 11, 2018

    Report

    Report Number
    1226348-2018-10051
    Event Type
    Malfunction
    Date Received
    January 11, 2018
    Date of Event
    December 21, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K061876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RETURNED FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    BOTH 510(K) #'S FOR THIS PRODUCT CODE: K061876 & K050739. (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE PROGRAMMER WAS RETURNED AND EVALUATED. THE PROGRAMMER WAS INSPECTED BY THE CODMAN REPAIR DEPARTMENT. THIS PROGRAMMER WAS RESET AND PASSED ALL TESTING. THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    PER (B)(4) PROGRAMMER OVERHEATING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26721 CODMAN VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1