BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 5978076 · Received September 26, 2016

    Report

    Report Number
    1226348-2016-10680
    Event Type
    Injury
    Date Received
    September 26, 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). THIS DEVICE HAS TWO 510 (K) #'S: K061876 & K050739. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE PRODUCT WAS TESTED AND IT WAS REPORTED THAT PROGRAMMATION FAILED AND THAT IT WAS A CRACK ON TRANSMITTER HEAD. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE PRODUCT WAS FORWARDED TO OUR SUPPLIER (B)(4): THE INVESTIGATION ON THE SUPPLIER DETECTED THAT TRANSMITTER HAS CRACKS AND THAT FRONT PANEL DISPLAY HAS SEVERAL SCRATCHES. TOP COVER, TRANSMITTER SWITCH, DOME PLUG AND FRONT PANEL HAS BEEN REPLACED. A DHR REVIEW WAS PERFORMED FOR THE VPV PROGRAMMER 82-3192 S/N: (B)(4) (LOT# CNDC10), AND THE LOT MET SPECIFICATIONS WHEN RELEASED ON APRIL 10TH, 2012. THE ROOT CAUSE OF THE PROBLEM WAS 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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628140 CODMAN VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CNDC10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention