BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 3384089 · Received October 3, 2013

    Report

    Report Number
    1226348-2013-29373
    Event Type
    Injury
    Date Received
    October 3, 2013
    Date of Event
    September 3, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC MEDOS
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE NEW MATRIX ON (B)(4) 2013, THIS EVENT IS BEING CLASSIFIED AS A SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT IS BEING FILED AS THE REP HAS CLARIFIED THAT THE COMPLAINT PERTAINED TO A VPV AND NOT THE VALVE. ALSO, SINCE THE SURGEON HAD DIFFICULTY AND APPEARS AND X-RAY WAS TAKEN THE COMPLAINT WILL BE RECLASSIFIED AS A SERIOUS INJURY RATHER THAN A MALFUNCTION. AS FAR AS THE REP IS AWARE, THE VALVE WAS NOT EXPLANTED. THE PATIENT WAS RELEASED.

    Additional Manufacturer Narrative · 1

    IT IS NOT CLEAR AT THIS POINT IF THE DEVICE AND/OR LOT INFORMATION IS AVAILABLE. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF THE DEVICE IS RETURNED THE COMPLAINT WILL BE INVESTIGATED AND A FOLLOW UP REPORT WILL BE FILED. IF LOT INFORMATION DOES BECOMES AVAILABLE AND IF THE RECORD REVIEW INDICATES THAT THERE WAS A NON-CONFORMITY A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT A VPV PROGRAMMER WITH TRANSMITTER HEAD WAS RETURNED FOR AN EVALUATION. AS RECEIVED NO DAMAGES WERE OBSERVED. THE VPV PROGRAMMER WAS FUNCTIONALLY CHECKED, AND IT WAS FOUND FULLY FUNCTIONAL. THE VPV PROGRAMMER SUCCESSFULLY PROGRAMMED A VALVE AT DIFFERENT SETTINGS WITHOUT ANY DIFFICULTY. A DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED AND IT 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.

    Description of Event or Problem · 1

    PER THE NEW MATRIX ON (B)(4) 2013, THIS EVENT IS BEING CLASSIFIED AS A SERIOUS INJURY.

    Description of Event or Problem · 1

    REP REPORTED THAT SEVERAL HOURS TO ADJUST AND COULD NOT GET VALVE TO PROGRAM. IT WAS NOTED THAT IT WAS ON THE SAME SETTING AS THE ADJUSTMENT IN MARCH. VALVE IS ON 50MMH2O. VALVE IS PROMINANT ON THE SCALP. PATIENT HAS LOTS OF ISSUES. VALVE SHOULD HAVE BEEN SENT TO 130. THE THOUGHT IS THAT THE XRAY MAY HAVE BEEN SHOT BACKWARDS. DOC WILL LEAVE AT 50.

    Description of Event or Problem · 1

    A FOLLOW UP REPORT IS BEING FILED AS THE REP HAS CLARIFIED THAT THE COMPLAINT PERTAINED TO A VPV AND NOT THE VALVE. ALSO, SINCE THE SURGEON HAD DIFFICULTY AND APPEARS AND X-RAY WAS TAKEN THE COMPLAINT WILL BE RECLASSIFIED AS A SERIOUS INJURY RATHER THAN A MALFUNCTION. AS FAR AS THE REP IS AWARE, THE VALVE WAS NOT EXPLANTED. THE PATIENT WAS RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499669 CODMAN VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF, INC MEDOS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention