BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 6195852 · Received December 21, 2016

    Report

    Report Number
    1226348-2016-10873
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Product Code
    JXG
    PMA / PMN Number
    K061876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED UDI: (B)(4). BOTH 510(K) #'S FOR THIS PRODUCT CODE: K061876 & K050739. UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE PRODUCT WAS RECEIVED IN (B)(4) ON DECEMBER 12TH, 2016. THE PRODUCT WAS TESTED IN CODMAN (B)(4) AND IT WAS REPORTED THAT THE UNIT HEAD IS BROKEN. THE ISSUE WAS CONFIRMED. THE DEVICE WAS FORWARDED TO OUR SUPPLIER (B)(4): THE INVESTIGATION ON THE SUPPLIER DETECTED THAT THE TRANSMITTER COVER HAD CRACKS, THE FRONT PANEL WAS DAMAGED AND THE PROGRAMMER BOX IS DAMAGED ON THE LEFT SIDE. THE TOP COVER, THE TRANSMITTER SWITCH, THE DOME PLUG, THE FRONT PANEL AND THE PROGRAMMER BOX WERE REPLACED. THE DEVICE WILL BE SHIPPED BACK TO THE SUPPLIER. A DHR REVIEW WAS PERFORMED FOR THE PROGRAMMER 82-3192, SN # (B)(4) (LOT # CHCCBH), AND THE LOT MET SPECIFICATIONS WHEN RELEASED ON MARCH 2ND, 2007. 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.

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PART NUMBER, UDI UNAVAILABLE. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    I WANTED TO REPORT AN ADVERSE EVENT THAT OCCURRED WHILE VISITING MY NEURO SURGEON'S OFFICE AT (B)(6) HOSPITAL. HIS PHYSICIAN'S ASSISTANT WAS ATTEMPTING TO RE-PROGRAM MY CODMAN HAKIM MEDOS PROGRAMMABLE VP SHUNT WHEN AS SHE PLACED THE HAND HELD PORTION OF THE UNIT AGAINST MY SKULL AND DEPRESSED THE BUTTON TO RE-PROGRAM THE SHUNT, WE HEARD AN ELECTRICAL POPPING NOISE, THEN SMOKE CAME FROM THE BACK OF THE UNIT IN THE SUITCASE AND SHE HAD TO BLOW OUT A FLAME!!! THANK GOODNESS NO ONE WAS INJURED, SHE HANDLED THE SITUATION WONDERFULLY. SHE IN PLUGGED THE UNIT AND ESCORTED ME SAFELY TO THE HALLWAY, I WAS SO FRIGHTENED I NEEDED THE REST ROOM! MY SHUNT WAS IMPLANTED BACK IN 2011 AND DESPITE RECOGNIZING THE BENEFITS OF HAVING IT I HAVE NEVER BECOME COMFORTABLE THAT THERE IS A DEVICE IMPLANTED INTO MY BRAIN. AN EVENT LIKE THIS HAS TAKEN MY LEVEL OF ANXIETY OVER THE TOP! I HOPE THAT YOU WILL GIVE THIS EVENT THE SERIOUS ATTENTION IT DESERVES, SO THAT YOU MAY ENSURE IT DOES NOT HAPPEN AGAIN. PER PATIENT, SHUNT WAS REPROGRAMMED USING ANOTHER UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845609 CODMAN VPV SYSTEM VALVE PROGRAMMER JXG CHCCBH

    Patients

    Seq Age Sex Outcome Treatment
    1