MAUDE Adverse Event Report: TECHNOMED EUROPE TECHNOMED EUROPE; DISPOSABLE SUBDERMAL NEEDLE ELECTRODE, PT/IR

Model Number	TE/S46-638
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: TECHNOMED EUROPE
• Common Device Name: DISPOSABLE SUBDERMAL NEEDLE ELECTRODE, PT/IR
• Manufacturer (Section D): TECHNOMED EUROPE; amerikalaan 71; maastricht-airport, limburg 6199 AE; NL 6199 AE
• Manufacturer (Section G): TECHNOMED ASIA; k.i. trikencana kav. 4-5, jl.; kopo katapang km 11; bandung, jawa barat 40921 ; ID 40921
• Manufacturer Contact: sanne habets ; amerikalaan 71; maastricht-airport, limburg 6199 -AE ; NL 6199 AE
• MDR Report Key: 15091862
• Report Number: 9710376-2022-00001
• Device Sequence Number: 17418715
• Product Code: GXZ
• UDI-Device Identifier: 08718375861530
• UDI-Public: 08718375861530
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K990015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: 505
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2023
• Device Model Number: TE/S46-638
• Device Catalogue Number: TE/S46-638
• Device Lot Number: 047126
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 83 KG