BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 4241371 · Received November 10, 2014

    Report

    Report Number
    1226348-2014-12086
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 20, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    GWM
    PMA / PMN Number
    PK914479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO CODMAN AND THE LOT AND SERIAL NUMBERS ARE UNKNOWN, SO NO EVALUATION WAS PERFORMED. THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE VERIFIED. THE COMPLAINT IS CONSIDERED CLOSED AT THIS TIME. IF THE DEVICE BECOMES AVAILABLE, THE COMPLAINT WILL BE REOPENED AND AN EVALUATION PERFORMED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE DEVICE WAS RETURNED ON 19DEC2014 AND THE COMPLAINT WAS REOPENED ON 22DEC2014 TO INCLUDE THE EVALUATION OF THE DEVICE. THE RETURNED DEVICE WAS EVALUATED. APPROXIMATELY A 12-INCH SECTION OF THE CATHETER WAS RETURNED. A KINK WAS OBSERVED APPROXIMATELY 4.5 INCHES FROM THE TIP OF THE SENSOR. THERE IS SUTURE ATTACHED TO THE CATHETER IN THE KINKED AREA. THE SEGMENT WAS RETURNED WITH THE WIRE EXPOSED AT THE BREAKAGE. AT THE POINT OF BREAKAGE, THE CATHETER MATERIAL SHOWED SIGNS OF BEING STRETCHED. THE DIAMETER OF THE CATHETER WAS THINNER TOWARD TO POINT OF BREAKAGE. WHILE WE CANNOT CONCLUSIVELY DETERMINE HOW THIS WAS BROKEN, IT APPEARS IT WAS INADVERTENTLY DAMAGED BY THE CUSTOMER DURING USE. A RECORD REVIEW COULD NOT BE CONDUCTED AS THE LOT/SERIAL NUMBER WAS NOT PROVIDED. 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: THE NEUROMONITORING CATHETER IS BREAKING INTO TWO PIECES, INCLUDING THE WIRE FILAMENT PLUS THE OUTER PROTECTIVE COATING. THIS IS A PRODUCT THAT HAS A PORTION OF THE CATHETER IN THE PATIENT'S HEAD. THIS HAS OCCURRED THREE TIMES. AFFILIATE IS FOLLOWING UP WITH THE CUSTOMER TO ENSURE PRIOR COMPLAINTS NOTED IN THE COMPLAINT HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723738 NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention