BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 6182669 · Received December 16, 2016

    Report

    Report Number
    1226348-2016-10861
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 23, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS PREVIOUSLY REPORTED THAT THE DEVICE WOULD NOT BE RETURNED. THE DEVICE WAS SUBSEQUENTLY MADE AVAILABLE FOR EVALUATION. THIS REPORT HAS BEEN UPDATED TO REFLECT THE CORRECTED INFORMATION. THE DEVICE HAS BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). THE 510(K) # OF SIMILAR PRODUCT CODE OF 826631: K914479. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPDATED UDI -- UPDATED UDI -- (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION BY THE SUPPLIER. REVIEW OF QUALITY RECORDS FOUND THAT THE DEVICE MET ALL MANUFACTURING AND QUALITY SPECIFICATIONS PRIOR TO DISTRIBUTION. EVALUATION OF THE RETURNED SENSOR FOUND THAT THE CATHETER MATERIAL WAS SEVERLY KINKED 17.5 CM FROM THE TIP OF THE CATHETER. THE DEVICE PASSED ALL ELECTRONICS, NOISE, LINEARITY/HYSTERESIS AND SIGNAL DRIFT TESTS. BASED ON THEIR EVALUATION, THE SUPPLIER WAS NOT ABLE TO CONFIRM THE REPORTED ISSUE. THE INSTRUMENT FUNCTIONED AS INTENDED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR EVALUATION. HOWEVER, MULTIPLE ATTEMPTS TO OBTAIN THE SAMPLE WERE NOT SUCCESSFUL. IF THE DEVICE IS RETURNED IN THE FUTURE, THE COMPLAINT WILL BE REOPENED AND A FOLLOW-UP REPORT WILL BE SUBMITTED. COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    THE PATIENT WAS SENT FOR A CT BRAIN SCAN POST OP AS THE DOCTORS COULDN'T RELY ON THE ICP READINGS TO BE ACCURATE. EVENTUALLY THE ICP READINGS BEGAN TO SETTLE. THE PATIENT IMPACT WAS HAVING TO GET S CT SCAN AS THE ICP DATA WAS UNRELIABLE. THE PROCEDURE WAS NOT EXTENDED. DETAILED EXPLANATION THE FEMALE PATIENT OF (B)(6) SUFFERED A HEAD INJURY ON (B)(6) 2016 FOLLOWING A FALL FROM A HORSE. DURING THIS ACCIDENT SHE ALSO FRACTURED HER T6 VERTEBRA. IT WAS DECIDED BY THE SURGICAL TEAM THAT SHE WOULD HAVE AN ICP MICROSENSOR IMPLANTED ON (B)(6) AND HER SPINE WILL BE OPERATED ON (B)(6). FROM (B)(6), THE ICP READINGS WERE APPROPRIATE FOR THE PATIENT CONDITION. ON (B)(6) THE PATIENT WENT TO SURGERY. DURING THIS SURGERY, EVERY TIME THE DIATHERMY WAS USED, THE ICP MONITOR WAS BEING INTERFERED WITH AND NO ICP READING WAS AVAILABLE. THE BOOMED ENGINEER WAS CALLED, THE ICP MONITOR AND CABLE WERE CHANGED BUT UNFORTUNATELY THE SAME SITUATION OCCURRED. THE SURGERY CONTINUED FOR APPROX 2HRS. POST OP THE READINGS OF THE ICP MONITORS WERE COMPLETELY IRREGULAR AND ERRATIC. THE DOCTORS DIDN'T BELIEVE THE READINGS TO BE RIGHT AND BELIEF THERE WAS Z DAILY WITH CODMAN MICROSENSOR 626631. THEY COULDN'T RELY ON THE ICP READINGS DO THEY HAD TO SCAN THE PATIENT TO UNDERSTAND HER INTRACRANIAL STATUS. THE PRODUCT IS DUE TO BE EXPLANTED OVER THE NEXT FEW DAYS AND I WILL ORGANISE FOR IT TO BE RETURNED FOR ASSESSMENT THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832018 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR