BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VPV SYSTEM

    MDR report key: 3552143 · Received January 6, 2014

    Report

    Report Number
    1226348-2014-10180
    Event Type
    Injury
    Date Received
    January 6, 2014
    Date of Event
    November 18, 2013
    Manufacturer
    CODMAN & SHURTLEFF, MEDOS
    Product Code
    JXG
    PMA / PMN Number
    PK061876
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT A VPV PROGRAMMER WITH TRANSMITTER HEAD WAS RETURNED FOR AN EVALUATION. AS RECEIVED IT WAS VERIFIED THAT THE PROGRAMMER COULD NOT CONFIRM THE SETTINGS DISPLAYING AN ERROR MESSAGE 'EXCESSIVE NOISE'. THE TRANSMITTER HEAD IS DAMAGED CAUSING THE DISPLAYED ERROR MESSAGE. THE CAUSE(S) OF THE DAMAGE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED, AND IT WAS VERIFIED THAT THIS VPV PROGRAMMER WAS CONFORMING TO THE REQUIRED SPECIFICATIONS WHEN RELEASED TO STOCK. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    510K: K061876 AND K050739. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    E-MAIL RECEIVED FROM THE SALES REP. INFORMED THAT: PLEASE SEND A NEW VPV UNIT OUT TODAY FOR (B)(4) MED CTR. THEY REPORTED THIS MORNING THAT THEY CANNOT GET THEIRS TO CONFIRM, BUT X-RAYS HAVE CONFIRMED THE SETTINGS HAVE BEEN PROPERLY CHANGED. THE UNIT IS SEVERAL YEARS OLD, NO PATIENTS WERE INJURED AND NO SURGERIES DELAYED BECAUSE OF THIS; IT¿S ONLY BEEN USED IN A CLINIC SETTING". 1/4/2014 BASED ON THE MATRIX THAT WENT INTO EFFECT ON 12/6/2013 THIS TYPE OF EVENT IS CONSIDERED A REPORTABLE EVENT CLASSIFIED AS A SERIOUS INJURY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6876 VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF, MEDOS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention