BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBDURAL POST CRANIOTOMY ICP MONITORING KIT

    MDR report key: 6307458 · Received February 7, 2017

    Report

    Report Number
    2023988-2017-00014
    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; EIGHT LOTS MODEL 110-4G SHIPPED TO THIS CUSTOMER FROM 01-JAN-2016 TO 15-JAN-2017. BATCH HISTORY RECORDS REVIEWED; THEY MET REQUIREMENTS BEFORE RELEASED TO FINISHED GOODS. COMPLAINTS HISTORY; THERE WERE 12 OTHER COMPLAINTS THAT ISSUED WITH COMPLAINT CODE PERF032, AND ONE OF THEM WAS CONFIRMED. FAILURE RATE PERCENTAGE 0.003%. CONCLUSION: COULD NOT BE CONFIRM SINCE THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION.

    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, 2023988-2017-00013, 2023988-2017-00011, 2023988-2017-00015, 2023988-2017-00016, 2023988-2017-00017, 2023988-2017-00018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91908 SUBDURAL POST CRANIOTOMY ICP MONITORING KIT N/A GWM INTEGRA NEUROSCIENCES CA/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 CAMINO MONITOR