BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBDURAL POST CRANIOTOMY ICP MONITORING KIT

    MDR report key: 6307456 · Received February 7, 2017

    Report

    Report Number
    2023988-2017-00013
    Event Type
    Malfunction
    Date Received
    February 7, 2017
    Report Date
    January 19, 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

    IT IS UNKNOWN IF THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS EXPECTED TO BE RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON MARCH 16, 2017. THE INVESTIGATION INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS; REVIEW OF COMPLAINTS HISTORY. RESULTS: THE CATHETER HAS NOT BEEN RETURNED FOR INVESTIGATION. DHR REVIEW; BATCH HISTORY RECORDS REVIEWED; THEY MET REQUIREMENTS BEFORE RELEASED TO FINISHED GOODS. COMPLAINTS HISTORY; (B)(4). CONCLUSION: 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

    THE PROBES ARE GIVING ERRATIC READINGS, FROM -5 TO 145 AND BACK TO 5 WHILE THE SURGEON IS TALKING TO THE PATIENT AND WATCHING THE MONITOR. THEY HAVE HAD FOUR 1104G PROBES WITH ISSUES IN THIS MONTH. THE HOSPITAL IS A REGULAR USER AND IS VERY AWARE OF HOW THE PRODUCT MUST BE USED. DISTRIBUTOR'S TECHNICIAN CHECKED THE MONITORS AND THEY ARE WORKING PERFECTLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. LINKED TO MFG. REPORT NUMBERS: 2023988-2017-00012, 2023988-2017-00011, 2023988-2017-00014, 2023988-2017-00015, 2023988-2017-00016, 2023988-2017-00017, 2023988-2017-00018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91960 SUBDURAL POST CRANIOTOMY ICP MONITORING KIT N/A GWM INTEGRA NEUROSCIENCES CA/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 CAMINO MONITOR