BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAKIM PROG VALVE, INTRODUCER, PLASTIC CONNECTOR

    MDR report key: 3200171 · Received July 1, 2013

    Report

    Report Number
    1226348-2013-20256
    Event Type
    Death
    Date Received
    July 1, 2013
    Date of Event
    December 6, 2012
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS HAVE BEEN CONDUCTED AND THEY REVEALED THAT THE DEVICE CONFORMED TO ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO BEING RELEASED TO STOCK. IF AT SOME POINT THE DEVICE IS RETURNED FOR EVALUATION, THIS COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. BASED ON THIS EVALUATION 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

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE 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.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT AN INCIDENT WITH A MORTAL OUTCOME HAS OCCURRED AT A HOSPITAL; IMPLANTS MANUFACTURED BY CODMAN HAD BEEN USED IN THE CARE OF THE PATIENT. THE DOCTOR INVOLVED WITH THIS CASE IS ON VACATION UNTIL (B)(6) 2013, THEREFORE NO ADDITIONAL INFORMATION IS AVAILABLE UNTIL HE RETURNS. IT IS ALSO NOT POSSIBLE TO DETERMINE IF THE DEVICES CAUSED OR CONTRIBUTED TO THE PATIENT¿S DEATH.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE AFFILIATE STATED THAT BASED ON THE REPORT RECEIVED FROM THE AUTHORITIES THE PATIENT WAS FOUND AT HOME AND "CONTACT COULD NOT BE REACHED". AT THE HOSPITAL, THE PATIENT WAS DECLARED DEAD. THE AFFILIATE REPORTED THAT THEY HAVE NOT BEEN ABLE TO RECEIVE MORE INFORMATION FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300455 HAKIM PROG VALVE, INTRODUCER, PLASTIC CONNECTOR SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC 1164107

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Death 82-3072