BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN HAKIM PROGRAMMER

    MDR report key: 6774461 · Received August 8, 2017

    Report

    Report Number
    1226348-2017-10551
    Event Type
    Malfunction
    Date Received
    August 8, 2017
    Date of Event
    July 19, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K003564
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT 82-32190 WAS RECEIVED IN CODMAN (B)(4). INSPECTION IN CODMAN (B)(4) HAS NO REPORTED ERROR MESSAGE ISSUE. DEVICE HAS BEEN RESET, CHECKED AND RETURNED TO CUSTOMER. A DHR REVIEW WAS PERFORMED FOR THE PROGRAMMER 82-3190 S/N: (B)(4) (LOT# CRJBK4), AND THE LOT MET SPECIFICATIONS WHEN RELEASED ON JULY 22ND, 2014.

    Description of Event or Problem · 1

    THE REPORTED VALVE WAS IMPLANTED TO A PATIENT VIA LP-SHUNT ON (B)(6) 2017 (INITIAL SETTING IS UNKNOWN). ON (B)(6) 2017, THE PRESSURE SETTING WAS NOT ABLE TO BE CHANGED BY USING PROGRAMMER (82-3190, SERIAL NUMBER IS UNKNOWN). AT THAT TIME, WHEN THE SURGEON RAISED THE PRESSURE SETTING, IT LOWERED, AND THE OPPOSITE CASE ALSO OCCURRED. SO THE SURGEON ATTEMPTED TO USE NEODYMIUM MAGNET TO CHANGE THE PRESSURE SETTING TO 100 MMH2O ON THE SAME DAY. ON (B)(6) 2017, THE SURGEON FOUND THAT THE VALVE IN QUESTION WAS BENDED UNDER CT. THE PATIENT¿S CONDITION IS NOW STABLE, SO A REVISION SURGERY IS NOT SCHEDULED SO FAR. THE SURGEON REQUESTED THE OFFICIAL STATEMENT OF THE VALVE CONDITION AS THE HOSPITAL PROVIDE THE CT IMAGE. THE PATIENT IS (B)(6) YEARS OLD, FEMALE, AND HER INITIAL IS (B)(6). THE PATIENT¿S CONDITION IS UNDER MONITORING. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554159 CODMAN HAKIM PROGRAMMER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CRJBK4

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR NS-9008