BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN LUMBAR EXT DR CATH

    MDR report key: 3521043 · Received December 16, 2013

    Report

    Report Number
    1226348-2013-36127
    Event Type
    Injury
    Date Received
    December 16, 2013
    Date of Event
    November 28, 2012
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK964923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE BE ADVISED THAT WE DO NOT USE THERAPY DATES, AS A RESULT TODAY'S DATE WAS USED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED FROM THE AFFILIATE AND STATED THAT AN EXTERNAL DRAINAGE SYSTEM 82-1731 WITH CATHETER 82-1706 WAS PLACED IN THE PATIENT. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND IS NOT AVAILABLE FOR EVALUATION. THE REVIEW OF THE HISTORY DEVICE RECORDS FOR LOT NUMBER CBHB71 WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT FOUND IN THE SYSTEM. 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.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT DURING THE CSF DRAINAGE, THE LINE BECAME DISCONNECTED AT THE INFERIOR LEVEL OF THE SAMPLING SITE AND THERE WAS A CSF LEAK. THE LINE WAS RECONNECTED URGENTLY THEN A NEW SYSTEM WAS PLACED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT DURING THE CSF DRAINAGE, THE LINE BECAME DISCONNECTED AT THE INFERIOR LEVEL OF THE SAMPLING SITE AND THERE WAS A CSF LEAK. THE LINE WAS RECONNECTED URGENTLY THEN A NEW SYSTEM WAS PLACED. ADDITIONAL INFORMATION FROM THE AFFILIATE STATED THAT AN EXTERNAL DRAINAGE SYSTEM 82-1731 WITH CATHETER 82-1706 WAS PLACED IN THE PATIENT.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED: DURING THE CSF DRAINAGE, THE LINE GOT DISCONNECTED AT THE INFERIOR LEVEL OF THE SAMPLING SITE. THERE WAS A CSF LEAK. THE LINE WAS RECONNECTED URGENTLY. THEN A NEW SYSTEM HAS BEEN PLACED. THE DEVICE IS AVAILABLE FOR EVALUATION. THE INCIDENT HAS BEEN REPORTED TO THE (B)(6). ON (B)(6) AFFILIATE RECEIVED ADDITIONAL INFORMATION, WE HAVE RECEIVED FURTHER DETAILS CONCERNING THE INCIDENT (B)(4) : ON (B)(6) 2013, AN EXTERNAL DRAINAGE SYSTEM , (B)(4), WAS PLACED ON A PATIENT., WITH A CATHETER (B)(4). ON (B)(6), DURING CFS DRAINAGE, THE LINE GET DISCONNECTED. A NEW DRAINAGE SYSTEM WAS PLACED ON (B)(6) 2013, LOT NO: CPKBRW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656131 CODMAN LUMBAR EXT DR CATH SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CBHB71

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 82-1731