BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 6419290 · Received March 20, 2017

    Report

    Report Number
    1226348-2017-10173
    Event Type
    Injury
    Date Received
    March 20, 2017
    Date of Event
    March 1, 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

    THE DEVICE HAS BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE PRODUCT WAS RECEIVED IN (B)(4) ON MARCH 21ST, 2017. THE PRODUCT WAS TESTED IN CODMAN (B)(4) AND IT WAS REPORTED THAT AN ERROR MESSAGE DISPLAYED. THE ISSUE WAS CONFIRMED. THE DEVICE WAS FORWARDED TO OUR SUPPLIER (B)(4): THE INVESTIGATION AT THE SUPPLIER DETECTED THAT THE FRONT PANEL WAS DAMAGED, THE TEMPERATURE SENSOR HAS NOT BEEN VERIFIED AND THE ATTACHÉ CASE WAS DAMAGED. THE FRONT PANEL AND THE ATTACHÉ CASE WERE REPLACED AND THE TEMPERATURE SENSOR WAS VERIFIED. THE DEVICE WILL BE SHIPPED BACK. AS THE ISSUE WAS RELATING TO A USER ERROR, NO DHR REVIEW WAS PERFORMED FOR THE VPV PROGRAMMER 82-3192, SN (B)(4)(LOT # CPMBK4). 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.

    Description of Event or Problem · 1

    DURING SHUNT REPROGRAMMING, ERROR MESSAGE CAME UP SAYING THE TRANSMITTER IS BROKEN. AS A RESULT, PATIENT HAS BEEN ADMITTED TO THE HOSPITAL WHILE A VPV PROGRAMMER IS SOURCED FROM ANOTHER HOSPITAL. PROCEDURE HAS BEEN RE-SCHEDULED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200281 CODMAN VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CPMBK4

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention