BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECHNOMED EUROPE

    MDR report key: 15091862 · Received July 25, 2022

    Report

    Report Number
    9710376-2022-00001
    Event Type
    Injury
    Date Received
    July 25, 2022
    Date of Event
    July 7, 2022
    Report Date
    July 25, 2022
    Manufacturer
    TECHNOMED EUROPE
    Product Code
    GXZ
    UDI-DI
    08718375861530
    PMA / PMN Number
    K990015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT DESCRIPTION AS IN E-MAIL FROM CUSTOMER: WE HAVE BEEN INFORMED BY ONE OF OUR TRADERS THAT A CUSTOMER HAS REPORTED AN INCIDENT WITH AN SDN ELECTRODE TO THE COMPETENT SPANISH AUTHORITY. AT THE MOMENT, WE DO NOT HAVE MORE DETAILED INFORMATION ABOUT THE SERIAL NUMBER AND THE BACKGROUND OF THE INCIDENT, NOR DO WE HAVE THE INITIAL REPORT TO THE AUTHORITIES. IT SEEMS THAT BURNS OCCURRED DURING USE. INCIDENT DESCRIPTION AS RECEIVED FROM AEMPS: SUBDERMAL IRIDIUM/PLATINUM ELECTRODES COMPATIBLE WITH MAGNETIC RESONANCE IMAGING, LOCATED IN THE HEAD, WERE USED FOR INTRAOPERATIVE NEUROPHYSIOLOGICAL MONITORING IN BRAIN TUMOR SURGERY. AFTER INTRODUCING THE PATIENT IN THE MRI, AND SUBSEQUENTLY PERFORMING THE CLOSURE, 3 BURNS IN THE HEAD ARE VERIFIED. NOT ALL THE ELECTRODES, ONLY IN 3 POSITIONS. CONSEQUENCES FOR THE PATIENT: MINOR HEAD BURNS. FURTHER COMMENT TECHNOMED: THE INCIDENT DESCRIPTION FROM AEMPS MENTIONS THAT THE PRODUCT IS MR COMPATIBLE. THE PRODUCT LABELLING DOES NOT STATE THAT THE PRODUCT IS MR COMPATIBLE.

    Description of Event or Problem · 0

    COMPLAINT DESCRIPTION AS IN E-MAIL FROM INOMED (12TH OF JULY): "WE HAVE BEEN INFORMED BY ONE OF OUR TRADERS THAT A CUSTOMER HAS REPORTED AN INCIDENT WITH AN SDN ELECTRODE TO THE COMPETENT SPANISH AUTHORITY. AT THE MOMENT, WE DO NOT HAVE MORE DETAILED INFORMATION ABOUT THE SERIAL NUMBER AND THE BACKGROUND OF THE INCIDENT, NOR DO WE HAVE THE INITIAL REPORT TO THE AUTHORITIES. IT SEEMS THAT BURNS OCCURRED DURING USE." FURTHER INFORMATION RECEIVED VIA INOMED FROM END USER (18TH OF JULY 2022): THERE WAS NO EQUIPMENT MALFUNCTION. ELECTROCAUTERY WAS USED. THE PRODUCT WAS USED FOR STIMULATION AND SIGNAL ACQUISITION PURPOSES. THE ELECTRODES WERE KEPT IN THE PATIENT WHILE THE PATIENT WAS IN THE MR COIL. NEUROPHYSIOLOGICAL MONITORING WAS PERFORMED OUTSIDE THE MR COIL (MRI MACHINE USED: PHILLIPS INGENIA 1.5 T. REF. 84313). EXPERIENCE OF USERS: NEUROSURGICAL INTERVENTIONS WITH INTRAOPERATIVE MONITORING HAVE BEEN PERFORMED IN OUR CENTER FOR THE LAST 3 YEARS BY THE SAME TEAM, MANY OF THEM WITH NEUROPHYSIOLOGICAL INTRAOPERATIVE MONITORING. ONE PATIENT WAS INVOLVED. THE BURNS WERE FIRST DEGREE BURNS (LONG TERM TISSUE DAMAGE IS RARE). NO FURTHER INTERVENTION WAS NEEDED TO TREAT THE BURNS. PATIENT WAS A MALE PATIENT, 35 YEARS OLD, 83 KG. THE TRADER INOMED HAS CONFIRMED THAT THEY PROVIDE MRI INFORMATION WITH EACH SHIPMENT AFTER TECHNOMED INFORMED THEM OF THE MRI INCOMPATIBILITY OF THE PRODUCT IN 2019. INOMED HAS A CHECKPOINT IN THEIR INCOMING GOOD EXAM FOR THIS PRODUCT. REGARDING THE BATCH FROM THIS ISSUE THE INCOMING GOOD EXAM IS UNREMARKABLE. INCIDENT DESCRIPTION AS RECEIVED FROM AEMPS (19TH OF JULY 2022): "SUBDERMAL IRIDIUM/PLATINUM ELECTRODES COMPATIBLE WITH MAGNETIC RESONANCE IMAGING, LOCATED IN THE HEAD, WERE USED FOR INTRAOPERATIVE NEUROPHYSIOLOGICAL MONITORING IN BRAIN TUMOR SURGERY. AFTER INTRODUCING THE PATIENT IN THE MRI, AND SUBSEQUENTLY PERFORMING THE CLOSURE, 3 BURNS IN THE HEAD ARE VERIFIED. NOT ALL THE ELECTRODES, ONLY IN 3 POSITIONS." CONSEQUENCES FOR THE PATIENT: "MINOR HEAD BURNS". FURTHER COMMENT TECHNOMED: THE INCIDENT DESCRIPTION FROM AEMPS MENTIONS THAT THE PRODUCT IS MR COMPATIBLE. THE PRODUCT LABELLING DOES NOT STATE THAT THE PRODUCT IS MR COMPATIBLE AND THE PRODUCT HAS NOT BEEN TESTED FOR USE IN MRI ENVIRONMENT. THEREFORE, THIS PRODUCT SHOULD NOT BE USED IN MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607323 TECHNOMED EUROPE DISPOSABLE SUBDERMAL NEEDLE ELECTRODE, PT/IR GXZ TECHNOMED EUROPE TE/S46-638 047126 08718375861530

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Other