BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 5220114 · Received November 12, 2015

    Report

    Report Number
    1226348-2015-10666
    Event Type
    Injury
    Date Received
    November 12, 2015
    Date of Event
    June 4, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    PK061876
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED BY THE SUPPLIER. THE SUPPLIER'S EVALUATION FOUND THAT THE TRANSMITTER WAS CRACKED. THE TRANSMITTER COVER, TRANSMITTER SWITCH AND DOME PLUG WERE REPLACED. THE SUPPLIER DETERMINED THAT THE REPORTED ISSUE WAS THE RESULT OF IMPROPER HANDLING OF THE DEVICE. THE LOT NUMBER HAS BEEN PROVIDED AND A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE PERFORMED. WE ANTICIPATE THAT THE REVIEW WILL CONFIRM THAT THE DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. IF ANYTHING OUT OF THE ORDINARY IS DETERMINED A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VALVE DIDN'T PROGRAM CORRECTLY. A BACKUP PROGRAMMER WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS A DELAY OF GREATER THAN 30 MINUTES IN THE PROCEDURE. HOWEVER, THERE WAS NO REPORTED ADVERSE OUTCOME TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750831 CODMAN VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention