BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBDURAL POST CRANIOTOMY ICP MONITORING KIT

    MDR report key: 4172277 · Received October 9, 2014

    Report

    Report Number
    2023988-2014-00051
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Report Date
    September 17, 2014
    Manufacturer
    INTEGRA NEURO SCIENCES
    Product Code
    GWM
    PMA / PMN Number
    K102875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE DISTRIBUTOR ON OCTOBER 29, 2014. THE PROBLEM OCCURRED PRIOR TO IMPLANTATION OF THE 1104G IN THE PT ON (B)(6) 2014. PT'S AGE, GENDER, TYPE OF SURGERY, EXACT LOT NUMBER OF THE 1104G WAS UNK. THERE WAS A REPLACEMENT CATHETER AVAILABLE AND USED. THERE WAS NO SURGERY/TREATMENT DELAY. INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 11/07/2014. THE PT INVESTIGATION INCLUDED. INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON NOVEMBER 7, 2014. THE INVESTIGATION INCLUDED METHODS, REVIEW OF DEVICE HISTORY RECORDS, REVIEW OF COMPLAINT HISTORY - RESULTS: THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF BATCH HISTORY RECORDS INDICATE THAT LOT 305C00304377, AND 305C00304364 MET REQUIREMENTS BEFORE RELEASED TO FINISHED GOODS. BOTH LOTS WERE MFG ON MAY 13, 2014, EXP APRIL 30, 2017. COMPLAINT HISTORY, MODEL 110-4XX, FROM OCTOBER 2013 THROUGH SEPTEMBER 2014 WAS REVIEWED AND THERE WERE (B)(4) OTHER COMPLAINTS THAT ISSUED CODE WITH COMPLAINT (B)(4), AND (B)(4) OF THEM WERE CONFIRMED. (B)(4). CONCLUSION: THE CUSTOMER'S COMPLAINT "ZERO ADJUSTMENT GOES WELL BUT THE SCREEN READS NO NUMBER WHEN CONNECTING WITH THE CATHETER AFTER PATIENT BACK TO WARD, EVEN CONNECTING TO ANOTHER MACHINE DID NOT WORK. THIS CASE OCCURRED TO THREE CATHETERS RECENTLY" COULD NOT BE CONFIRMED. SINCE THE CUSTOMER DID NOT RETURNED THE PRODUCT FOR EVALUATION AND NO FURTHER INFORMATION ON THE DEVICE WAS PROVIDED, NO CONCLUSIONS COULD BE DRAWN, NOR ROOT CAUSE ESTABLISHED WITHOUT HAVING THE ACTUAL DEVICE TO EVALUATE AND ANALYZE. INTEGRA CONSIDERS THIS COMPLAINT CLOSED FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION 06/23/2015. METHOD, DEVICE EVAL, REVIEW OF DEVICE HISTORY RECORDS, REVIEW OF COMPLAINT HISTORY - RESULTS: THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED. THE RETURNED DEVICE WAS FUNCTIONALLY TESTED AND MET SPECIFICATIONS, THE CATHETER WAS THEN PLACE ON A 24 HOUR STABILITY TEST, AND THE CATHETER MET REQUIREMENTS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ANOMALIES, THE CATHETERS MEET SPECIFICATIONS PRIOR TO STERILIZATION. SINCE THE DEVICE MET SPECIFICATIONS AND NO FURTHER INFORMATION ON THE INCIDENT WAS PROVIDED NO FURTHER ACTION CAN BE PERFORMED. IT SHOULD BE NOTED THAT IT IS A POSSIBILITY THAT THE CUSTOMER DID NOT SECURE - THE CATHETER TO THE PATIENT SKULL PER THE DIRECTIONS IN THE DIRECTIONS FOR USE IF THE CATHETER WAS SECURED PROPERLY THE CATHETER SHOULD HAVE INDENTATIONS FROM THE SUTURES, THERE IS NONE PRESENT. ALL CUSTOMER COMPLAINTS ARE REVIEWED FOR TRENDS DURING THE QUALITY MANAGEMENT REVIEW.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. THE PRODUCT HAS BEEN DISCARDED BY THE CUSTOMER. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INTRACRANIAL PRESSURE (ICP) NUMBER SURGES. AFTER TWO DAYS OF CATHETER INSERTION, THE PATIENT FELT SLIGHTLY BAD AND THE NUMBER SUDDENLY SOARED TO OVER 110. AFTER 2 HOURS, IT SLOWLY WENT BACK TO NORMAL RANGE. DURING THIS PERIOD, THE PATIENT'S VITAL SIGNS ALL PROVED TO BE NORMAL. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT TO DATE, NO NEW INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636971 SUBDURAL POST CRANIOTOMY ICP MONITORING KIT NA GWM INTEGRA NEURO SCIENCES 305C00304377 OR 305C00304364

    Patients

    Seq Age Sex Outcome Treatment
    1