BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 5992689 · Received October 1, 2016

    Report

    Report Number
    1226348-2016-10697
    Event Type
    Injury
    Date Received
    October 1, 2016
    Date of Event
    September 7, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K061876
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    IT HAS BEEN DISCOVERED THAT THE REPORT ASSOCIATED WITH THIS EVENT IS A DUPLICATE OF THAT FILED UNDER MDR 26348-2016-10680. PLEASE REFER TO THAT REPORT FOR INFORMATION REGARDING THE REPORTED EVENT.

    Description of Event or Problem · 1

    ELSG TAGE REPORT VPV VALVE PROGRAMMER REPAIR OF UNIT DESCRIPTION OF FAILURE: AS BEFORE - PROGRAMMER SOMETIMES THE VALVE PROGRAMS THEN SAYS PROGRAMMING FAILED AND TRY AGAIN, HOWEVER IT IS SETTING THE VALVE BUT SOMETIMES IT FAILS. PATIENT HAS TO GO FOR X- RAY TO CONFIRM. DEVICE ERROR MESSAGE: NO OTHER INFORMATION AVAILABLE. WHEN WAS THE PROBLEM DISCOVERED?: PRE-OPERATIVELY. SURGICAL DELAY?: NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644080 CODMAN VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention