BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 6307468 · Received February 7, 2017

    Report

    Report Number
    2023988-2017-00015
    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; THE CUSTOMER DID NOT PROVIDE THE CATHETER LOT /SERIAL NUMBER. THERE WERE (B)(4) LOTS MODEL 110-4B SHIPPED TO THE CUSTOMER FROM JANUARY 1ST 2016 TO JANUARY 15TH 2017; THEIR BATCH HISTORY RECORDS INDICATING THAT ALL REQUIREMENTS MET BEFORE THEY WERE RELEASED TO FINISHED GOODS. COMPLAINTS HISTORY; (B)(4). 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. THE HOSPITAL IS A REGULAR USER WITH GOOD EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. LINKED TO MFG. REPORT NUMBERS: 2023988-2017-00012, 2023988-2017-00013, 2023988-2017-00014, 2023988-2017-00011, 2023988-2017-00016, 2023988-2017-00017, 2023988-2017-00018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91930 OLM INTRACRANIAL PRESSURE MONITORING KIT N/A GWM INTEGRA NEUROSCIENCES CA/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 CAMINO MONITOR