BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 6300470 · Received February 3, 2017

    Report

    Report Number
    2023988-2017-00008
    Event Type
    Malfunction
    Date Received
    February 3, 2017
    Report Date
    January 20, 2017
    Manufacturer
    INTEGRA NEUROSCIENCES CA/USA
    Product Code
    GWM
    PMA / PMN Number
    K102875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 3/07/2017. METHOD: -DHR REVIEW -TREND ANALYSIS -FAILURE ANALYSIS THE CATHETER HAS NOT BEEN RETURNED FOR INVESTIGATION. THREE LOTS HAVE BEEN USED RECENTLY USED IN THE CUSTOMER FACILITY WAS REVIEWED; THEY MET SPECIFICATIONS BEFORE RELEASED TO FINISHED GOODS: LOT NO., MFG DATE, EXP. DATE: 111E00227069, 18-FEB-2016, 31-JAN-2019; 111E00279816, 28-JUN-2016, 30-JUN-2019; 111E00279658, 14 JUN-2016, 31-MAY-2019. . COMPLAINT HISTORY, MODEL 110-4XXX, FROM FEB-2016 THROUGH JAN-2017 REVIEWED; THERE WERE THREE OTHER COMPLAINTS THAT ISSUED WITH COMPLAINT CODE (B)(4), AND NONE OF THEM WAS CONFIRMED. THE NUMBER OF CONFIRMED REPORTS (0 ) DIVIDED BY THE NUMBER OF UNITS SOLD MODEL 110-4XXX, ((B)(4)) MULTIPLIED BY 100 RESULTS IN A FAILURE RATE PERCENTAGE 0.00%. CONCLUSION: THE CUSTOMER¿S COMPLAINT COULD NOT BE CONFIRMED SINCE THE CUSTOMER DID NOT RETURN THE CATHETER FOR EVALUATION AFTER SEVERAL DOCUMENTED ATTEMPTS. THE DEVICE HISTORY RECORDS FOR THE POSSIBLE LOT NUMBERS THE CUSTOMER REPORTED WERE REVIEWED DID NOT REVEAL ANY ANOMALIES OBSERVED DURING THE MANUFACTURING, PACKAGING OR INSPECTION OF THE DEVICE OR ACCESSORIES WHILE IN PROCESS. ADDITIONALLY, BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION, NO ROOT CAUSE COULD BE ESTABLISHED FOR THE FAILURE MODE DESCRIBED IN THE CUSTOMER COMPLAINT.

    Description of Event or Problem · 1

    FOUR PATIENTS PRESENTED WITH VERY HIGH INTRACRANIAL PRESSURE (ICP) READINGS (60-80 MMHG) POST IMPLANTATION. THESE READING WERE NOT ACCEPTED BY THE NEUROSURGEONS. THE PATIENTS WERE SENT FOR CT SCAN/MAGNETIC RESONANCE IMAGING AND APPEARED TO HAVE "PLENTY OF SPACE". UPON REMOVAL, ONE OF THE 110-4B CATHETERS WAS FOUND TO BE "BENT". THE ISSUE INCREASED THE TIME FOR FOLLOWING PATIENT PRESSURE. ADDITIONAL INFORMATION RECEIVED ON 24JAN2017 WITH THE FOLLOWING: THE PATIENT FOR THIS PARTICULAR REPORT IS A (B)(6) MALE PATIENT WITH HEAD TRAUMA. THE CATHETER WAS PLACED ON OR AROUND (B)(6) 2017. THE ICP READING WAS ELEVATED AND THE MONITOR WAS CHANGED MULTIPLE TIMES. THE ICP CATHETER WAS NOT RETAINED. THERE WAS NO PATIENT INJURY REPORTED. THE FOLLOWING LOT NUMBERS FOR THE 1104-BT CATHETERS HAVE BEEN USED RECENTLY AND ONE OF THESE COULD HAVE BEEN USED ON THIS PATIENT: LOT NUMBERS: 111E00227069, 111E00279658, OR 111E00279816. LINKED TO MFG. REPORT NUMBERS: 2023988-2017-00006, 2023988-2017-00007, 2023988-2017-00005, 3006697299-2017-00018, 3006697299-2017-00019, 3006697299-2017-00020, 3006697299-2017-00021, 3006697299-2017-00022, 3006697299-2017-00023, 3006697299-2017-00024, 3006697299-2017-00025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82597 OLM INTRACRANIAL PRESSURE MONITORING KIT N/A GWM INTEGRA NEUROSCIENCES CA/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR