BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 6450191 · Received March 31, 2017

    Report

    Report Number
    1226348-2017-10217
    Event Type
    Injury
    Date Received
    March 31, 2017
    Date of Event
    March 8, 2017
    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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE PRODUCT WAS RECEIVED IN (B)(4) ON APRIL 5TH, 2017. THE PRODUCT WAS TESTED IN CODMAN (B)(4) AND IT WAS REPORTED THERE WERE CRACKS ON TRANSMITTER HEAD, BUT NO ISSUE WITH THE VALVE SETTINGS. THE ISSUE WAS NOT CONFIRMED. THE DEVICE WAS FORWARDED TO OUR SUPPLIER HMT: THE INVESTIGATION AT THE SUPPLIER DETECTED THAT THE TRANSMITTER COVER WAS BROKEN. THE TOP COVER, THE TRANSMITTER SWITCH AND THE DOME PLUG WERE REPLACED. THE DEVICE WILL BE SHIPPED BACK TO THE CUSTOMER. AS THE ISSUE WAS RELATING TO A USER ERROR, NO DHR REVIEW WAS PERFORMED FOR THE VPV PROGRAMMER 82-3192, SN # (B)(4) (LOT # CMCBLL). THE ROOT CAUSES OF THE PROBLEM WERE DUE TO A BAD HANDLING. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). BOTH 510(K) #'S: K061876 & K050739. IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    DID THE REPORTED EVENT CAUSE ANY DELAYS IN THE PROCEDURE OR SURGERY OVER 30 MINUTES? NO. BESIDES THE X-RAY TO CONFIRM THE SETTINGS, WERE THERE ANY ADVERSE CONSEQUENCES TO THE PATIENT? NO.

    Description of Event or Problem · 1

    AS REPORTED BY AFFILIATE, A VPV FAILED TO CONFIRM VALVE SETTINGS CHANGES. EVENT OCCURRED AT POST OP SETTING CHANGE; XRAY USED TO CONFIRM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233211 CODMAN VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CMCBLL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention