BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 6399007 · Received March 13, 2017

    Report

    Report Number
    1226348-2017-10151
    Event Type
    Malfunction
    Date Received
    March 13, 2017
    Date of Event
    February 20, 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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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

    UDI - (B)(4). THE PRODUCT WAS TESTED IN CODMAN (B)(4) AND IT WAS REPORTED THAT THE MESSAGE ¿REPEAT ADJUSTMENT¿ DISPLAYED. THE ISSUE WAS CONFIRMED. THE DEVICE WAS FORWARDED TO THE SUPPLIER. THE INVESTIGATION AT THE SUPPLIER DETECTED THAT THERE WAS A BAD CONNECTION IN THE SENSING UNIT. THE TRANSMITTER CABLE WAS REPLACED. THE DEVICE WILL BE SHIPPED BACK TO THE CUSTOMER. A DHR REVIEW WAS PERFORMED FOR THE PROGRAMMER 82-3192 S/N: (B)(4) (LOT# CJPBDV), AND THE LOT MET SPECIFICATIONS WHEN RELEASED ON DECEMBER 11TH, 2008. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    THE CLINICIAN CONTACTED ME TO REPORT THAT HE WAS TRYING TO PROGRAM A VALVE HE HAD RECENTLY IMPLANTED INTO A PATIENT USING THE LOAN VPV PROGRAMMER CONSIGNED TO HIS ROOMS, HOWEVER HE WAS NOT HAVING ANY LUCK AS THE TRANSMITTER HEAD ON THE VPV PROGRAMMER WAS HEATING UP AND FLASHING AN ERROR MESSAGE. REP VISITED THE CLINICIAN'S ROOMS YESTERDAY TO DROP OFF A WORKING LOAN VPV PROGRAMMER AND TO TEST IF THE TRANSMITTER HEAD WAS HEATING UP AND THE REP CAN CONFIRM THAT THIS IS TRUE. PT WAS UNABLE TO HAVE THEIR VALVE ADJUSTED UNTIL 1 DAY LATER, WHEN REP DROPPED OFF A LOAN UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182341 CODMAN VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CJPBDV

    Patients

    Seq Age Sex Outcome Treatment
    1