BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN LUMBAR CATHETER KIT

    MDR report key: 3961906 · Received July 28, 2014

    Report

    Report Number
    1226348-2014-11857
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 14, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    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

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

    Additional Manufacturer Narrative · 1

    REPORTED CODMAN LUMBAR CATHETER P/N 82-1707; LOT # 491476 WAS NOT RETURNED TO CODMAN; THEREFORE, THE EVALUATION COULD NOT BE PERFORMED. IN THE ABSENCE OF THE COMPLAINT SAMPLE, A LOT HISTORY RECORDS REVIEW WAS CONDUCTED, AND IT WAS VERIFIED THAT ALL PRODUCTS IN THIS LOT NUMBER WERE CONFORMING TO THE REQUIRED SPECIFICATIONS WHEN RELEASED TO STOCK ON MARCH 18, 2014. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. COMPLAINT IS CONSIDERED CLOSED AT THIS TIME. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE THIS COMPLAINT WILL BE REOPENED AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    RUPTURE OF DRAINAGE CATHETER DURING REMOVAL. IT WAS LOCATED BETWEEN 2 LATERAL PERFORATIONS. A PART OF THE CATHETER (3 TO 4 CM) REMAINED IN THE PATIENT (INTERVERTEBRAL). NO USE OF EXCESSIVE FORCE. IT SEEMS THAT THE DEVICE WAS FRAGILE AT THE LATERAL PERFORATION LEVEL. THE PATIENT HAS NO PAIN AND THERE IS NO LEAK AT THE PUNCTION LEVEL. A RADIOLOGICAL AND NEUROSURGICAL FOLLOW UP IS PLANNED. THE HOSPITAL HAS REPORTED THE INCIDENT TO THE ANSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438116 CODMAN LUMBAR CATHETER KIT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF 491476

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention