BEUDAMED
    FDA Adverse Event Death Summary report: N

    BACTISEAL EVD 1.9MM CATH SET

    MDR report key: 3262661 · Received August 2, 2013

    Report

    Report Number
    1226348-2013-22904
    Event Type
    Death
    Date Received
    August 2, 2013
    Date of Event
    July 19, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK021653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE PRODUCT WAS DISCARDED BY THE CUSTOMER; THEREFORE, THE EVALUATION COULD NOT BE PERFORMED. IN THE ABSENCE OF THE COMPLAINT SAMPLE THE LOT HISTORY RECORDS FOR P/N 82-1749; LOT # 346619 WERE REVIEWED, AND IT WAS VERIFIED THAT ALL PRODUCTS IN THIS LOT NUMBER CONFORMED TO THE REQUIRED SPECIFICATIONS WHEN RELEASED TO STOCK. 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. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ON 4/17/2014 WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. THIS REPORT IS BEING FILED FROM MALFUNCTION TO SERIOUS INJURY.

    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.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT AFTER IMPLANTATION, THE PATIENT DEVELOPED VENTRICULITIS. THE PATIENT DIED, HOWEVER THE PHYSICIAN NOTED THE CAUSE OF DEATH WAS NOT RELATED TO VENTRICULITIS. THE PATIENT HAD MULTIPLE MEDICAL PROBLEMS INCLUDING SUBARACHNOID HEMORRHAGE AND A BRAIN ANEURYSM.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT THE PATIENT HAD THE IMPLANT IN FOR 2-3 WEEKS AND PATIENT DEVELOPED VENTRICULITIS. PATIENT DIED BUT CAUSE OF DEATH WAS NOT DUE TO VENTRICULITIS. PATIENT HAD MULTIPLE MEDICAL PROBLEMS - LONG HISTORY OF MEDICAL PROBLEMS - SUBARACHNOID HAEMORRHAGE AND BRAIN ANEURYSM COILING. PRODUCT EXPIRY: 2014-02. THE SAMPLE WAS DISCARDED. ON 4/17/2014 WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. THIS REPORT IS BEING FILED FROM MALFUNCTION TO SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362455 BACTISEAL EVD 1.9MM CATH SET SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R