BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 6798870 · Received August 16, 2017

    Report

    Report Number
    1226348-2017-10625
    Event Type
    Malfunction
    Date Received
    August 16, 2017
    Date of Event
    August 14, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K061876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BOTH 510(K) #'S ASSOCIATED WITH THIS DEVICE: 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 AUGUST 16TH, 2017. INSPECTION IN CODMAN (B)(4) REPORTED THAT AN ERROR MESSAGE DISPLAYED "INCOMPLETE ADJUSTMENT MESSAGE". A RESET WAS PERFORMED AND DEVICE WORKS NORMALLY AFTER IT. DEVICE WILL BE SHIPPED BACK TO CUSTOMER. A DHR REVIEW WAS PERFORMED FOR THE VPV PROGRAMMER 82-3192, S/N: (B)(4) (LOT# CPNBV3), AND THE LOT MET SPECIFICATIONS WHEN RELEASED ON NOVEMBER 14TH, 2013. THE ROOT CAUSE OF THE ERROR MESSAGE DISPLAYED COULD NOT BE DETERMINED. 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

    OUS CUSTOMER REPORTED 823192, THE EQUIPMENT OVERHEATS AND DOES NOT ALLOW PROPER PROGRAMMING. NO REPORTED HARM OR DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579372 CODMAN VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CPNBV3

    Patients

    Seq Age Sex Outcome Treatment
    1