BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIA AMBITION X

    MDR report key: 16848080 · Received May 1, 2023

    Report

    Report Number
    3003768277-2023-02617
    Event Type
    Malfunction
    Date Received
    May 1, 2023
    Date of Event
    April 17, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    LNH
    UDI-DI
    00884838090040
    PMA / PMN Number
    K18479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS WITHIN EMDR BASED ON INVESTIGATION CONCLUSION. THE CUSTOMER STATES THAT DESPITE FOLLOWING ALL THE SAFETY RECOMMENDATIONS OF THE IMPLANT MANUFACTURER, AND APPLYING THE RELEVANT LIMITATIONS IN THE SCANWISE TOOL, A PATIENT WITH A COCHLEAR IMPLANT REPORTED PAIN UPON ENTERING THE MRI SUITE. THE PATIENT WAS REMOVED IMMEDIATELY AND THERE WERE NO HEALTH CONSEQUENCES TO THE PATIENT. THE REPORTED PAIN IS CATEGORIZED AS A MINOR INJURY AND DOES NOT MEET THE CRITERIA FOR A SERIOUS INJURY AS NO HEALTH CONSEQUENCES WAS DOCUMENTED TO HAVE OCCURRED. INVESTIGATION WAS PERFORMED -LOGFILE ANALYSIS AND TESTING OF THE MRI SYSTEM FOUND NO INDICATIONS THAT THE MRI SYSTEM MALFUNCTIONED OR THAT USE ERROR HAD OCCURRED; THE MRI SYSTEM IS OPERATING TO PRODUCT SPECIFICATIONS. IN ADDITION, THE CUSTOMER CONFIRMED THAT THE COCHLEAR¿S NUCLEUS IMPLANTS MRI SAFETY CHECKLIST AND GUIDELINES WERE FOLLOWED. BASED ON THIS CONCLUSION, THIS EVENT IS CONSIDERED NOT REPORTABLE. THE MANUFACTURER OF THE IMPLANT IS AWARE OF THIS EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER STATES THAT DESPITE FOLLOWING ALL THE SAFETY RECOMMENDATIONS OF THE IMPLANT MANUFACTURER, AND APPLYING THE RELEVANT LIMITATIONS IN THE SCANWISE TOOL, A PATIENT WITH A COCHLEAR IMPLANT REPORTED PAIN UPON ENTERING THE MRI SUITE. THE PATIENT WAS REMOVED IMMEDIATELY AND THERE WERE NO HEALTH CONSEQUENCES TO THE PATIENT. THE REPORTED PAIN IS CATEGORIZED AS A MINOR INJURY AND DOES NOT MEET THE CRITERIA FOR A SERIOUS INJURY AS NO HEALTH CONSEQUENCES WAS DOCUMENTED TO HAVE OCCURRED.

    Description of Event or Problem · 0

    A CLINICAL ASSESSMENT PERFORMED BASED ON THE CURRENTLY AVAILABLE INFORMATION WITHIN THE COMPLAINT RECORD. THE CUSTOMER STATES THAT A PATIENT WITH A COCHLEAR IMPLANT REPORTED PAIN UPON ENTERING THE MRI SUITE. THE PATIENT WAS REMOVED IMMEDIATELY AND THERE WERE NO HEALTH CONSEQUENCES TO THE PATIENT. THE REPORTED PAIN IS CATEGORIZED AS A MINOR INJURY AND DOES NOT MEET THE CRITERIA FOR A SERIOUS INJURY AS NO HEALTH CONSEQUENCES WAS DOCUMENTED TO HAVE OCCURRED. OUT OF AN ABUNDANCE OF CAUTION WE HAVE CONCLUDED THAT THIS IS A REPORTABLE EVENT. THIS EVENT IS UNDER INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152863 INGENIA AMBITION X INGENIA AMBITION X LNH PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENIA AMBITION X 00884838090040

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown