BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 2054135 · Received March 3, 2011

    Report

    Report Number
    2023988-2011-00006
    Event Type
    Malfunction
    Date Received
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    INTEGRA NEUROSCIENCES SD
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA LIFESCIENCES ENGINEERS HAVE COMPLETED A DEVICE EVALUATION BASED ON THE REPORTED INFORMATION ONLY. THE COMPLAINT COULD NOT BE VERIFIED, BECAUSE, THE PRODUCT WAS NOT RECEIVED. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION RECEIVED ON (B)(6) 2011 REGARDING AN OLM INTRACRANIAL MONITORING DEVICE MAKES THIS COMPLAINT REPORTABLE BASED ON THE FACT THAT THE UNIT WAS IN CONTACT WITH THE PATIENT AT THE TIME OF THE EVENT. THE UNIT AN (OLM) INTRACRANIAL MONITORING DEVICE STOPPED FUNCTIONING AFTER ONE HOUR OF USE, THERE WAS NO SIGNAL. THERE WAS PATIENT CONTACT, BUT IT IS UNKNOWN WHETHER THERE WAS ANY PATIENT INJURY INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLM INTRACRANIAL PRESSURE MONITORING KIT NA GWM INTEGRA NEUROSCIENCES SD 305000185356

    Patients

    Seq Age Sex Outcome Treatment
    1