BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VPV SYSTEM

    MDR report key: 3552139 · Received January 6, 2014

    Report

    Report Number
    1226348-2014-10177
    Event Type
    Injury
    Date Received
    January 6, 2014
    Date of Event
    September 3, 2013
    Manufacturer
    CODMAN & SHURTLEFF MEDOS
    Product Code
    JXG
    PMA / PMN Number
    PK061876
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    510K: K061876 & K050739. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    REP REPORTED THAT CLINICIAN WAS ATTEMPTING TO RE-PROGRAM A SHUNT BEING USED IN THE LUMBAR REGION ON FLEURO. THE SETTINGS WERE BOUNCING EVERYWHERE BUT WHERE IT SHOULD HAVE BEEN. THEY WERE EVENTUALLY ABLE TO PROGRAM THE PRESSURE TO THE DESIRED SETTING. NO ADVERSE CONSEQUENCES. (B)(6) 2014, BASED ON THE NEW MATRIX THAT WENT INTO EFFECT, THIS COMPLAINT IS CONSIDERED TO BE A REPORTABLE EVENT CLASSIFIED AS A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7250 VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF MEDOS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention