MAUDE Adverse Event Report: LEONHARD LANG GMBH SKINTACT; ECG ELECTRODE

Model Number F-601C

Device Problem Insufficient Information (3190)

Patient Problems Partial thickness (Second Degree) Burn (2694); Blister (4537); Skin Burning Sensation (4540)

Event Date 06/29/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, we have been informed about an incident with ecg electrodes at blois hospital, in france.Skintact electrodes model f601c, lot number 230202-0189 were used.The complainant reported "please you can find below a complaint about -(b)(4).- lot: 230202-0189.This electrode was used with an irm.- and some patients have been burned.I am waiting for more informaitons.Have you some recommandations in a first time?" on (b)(6), we have received a partially filled questionnaire and picture showing the patient injury.It was stated that a 10 minutes cardio mri was performed on the patient.A philips mri monitor and 8 skintact ecg electrodes model f601c have been used.The patient was described as normal built with a normal skin.The patient was sweating.The skin preparation was described as shaven, not cleaned, not disinfected and not dried.After the procedure underneath 6 of the 8 applied ecg electrodes, in the centre of the ecg electrodes redness and burnt blisters have been detected.The size was described as ovoid 5mm in diameter.The skin injury was treated by medical treatment.In an e-mail it was additionally reported that "yes the patient is ok, mainly psychological impact.He felt intense heat in the chest with a pain.He says he was cooking in the mri" it was also reported that 5 days after the mri the patient "still have redness".No further details have been disclosed so far.

Manufacturer Narrative

Retained samples of the concerned lot of model f601c have been inspected visually.All inspected samples were found to perform within limits.We also have reviewed the product history records for the concerend lot number.No faults could be detected.We are awaiting customer samples for further testing.It was reported "i will send some samples as soon." we will provide a follow up report once further information respectively test results are available.

Event Description

On june 30th, 2023, we have been informed about an incident with ecg electrodes at (b)(6).Skintact electrodes model: f601c, lot number: 230202-0189 were used.The complainant reported "please you can find below a complaint about -f601c.Lot: 230202-0189.This electrode was used with an irm and some patients have been burned.I am waiting for more informations.Have you some recommendations in a first time?" on july we have received a partially filled questionnaire and picture showing the patient injury.It was stated that a 10 minutes cardio mri was performed on the patient.A philips mri monitor and 8 skintact ecg electrodes model: f601c have been used.The patient was described as normal built with a normal skin.The patient was sweating.The skin preparation was described as shaven, not cleaned, not disinfected and not dried.After the procedure underneath 6 of the 8 applied ecg electrodes, in the centre of the ecg electrodes redness and burnt blisters have been detected.The size was described as ovoid 5mm in diameter.The skin injury was treated by medical treatment.In an e-mail it was additionally reported that "yes the patient is ok, mainly psychological impact.He felt intense heat in the chest with a pain.He says he was cooking in the mri" it was also reported that 5 days after the mri the patient "still have redness".No further details have been disclosed.

Manufacturer Narrative

Retained samples of the concerned lot of model: f601c have been inspected visually.All inspected samples were found to perform within limits.We also have reviewed the product history records for the concerned lot number.No faults could be detected.On july 25th, 2023, we received 3 customer sample pouches.One pouch was originally sealed (pouch#: 2653 / lot: 230202-0189).Two pouches had already been opened by the customer (pouch#: 2655 / lot: 230202-0189 / content: 5 electrodes) and (pouch#: 2656 / lot: 230202-0189 / content: 30 electrodes).After requesting further information we have been informed that "i can confirm that the 2 open pouches have been taken from the ones used during the incident." the visual inspection of all returned customer samples have shown no failure of the electrodes.All returned customer samples show a carbon eylet - carbon stud button pairing.We additionally have requested the mri settings used during the patient incident and have received the information dated on (b)(6) 2023 that "the client has not been able to answer us so i think that we will not get any further information." it is unclear as to what has caused the claimed patient incident.However the ifu states the caution: "non-clinical testing has demonstrated that ecg electrodes are mr conditional.A patient with this device applied can be safely scanned in an mri system meeting the following conditions: static magnetic field of 1.5 teslas and 3 teslas, with maximum spatial field gradient of 12,800 g/cm (128 t/m) maximum force product of 231 t²/m.Theoretically estimated maximum whole body averaged (wba) specific absorption rate (sar) of 2 w/kg (normal operating mode), or 4 w/kg (first level controlled operating mode) after 15 minutes of continuous scanning, under the scanning conditions defined above, the ecg electrodes are expected to produce a maximum temperature rise of less than 1.7 °c (2 w/kg, 1.5 teslas) or 3.4 °c (4 w/kg, 1.5 teslas) hfrelated temperature increase with a background temperature rise of approx.1.2 °c (2 w/kg, 1.5 teslas) or 2.5 °c (4 w/kg, 1.5 teslas), 1.3 °c (2 w/kg, 3 teslas) or 2.7 °c (4 w/kg, 3 teslas) hf-related temperature increase with a background temperature rise of approx.0.9 °c (2 w/kg, 3 teslas) or 1.8 °c (4 w/kg, 3 teslas).In non-clinical testing, the image artefact caused by the device extends approximately 4.79 mm from the ecg electrodes when imaged with a gradient echo pulse sequence and a 3 tesla mri system." as no root cause can be detected no conclusion can be drawn.We therefore consider the investigation and the report closed.

• Brand Name: SKINTACT
• Type of Device: ECG ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• Manufacturer (Section G): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• Manufacturer Contact: bernhard ladner ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 17377150
• MDR Text Key: 319711806
• Report Number: 8020045-2023-00021
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K023503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2023
• Device Model Number: F-601C
• Device Lot Number: 230202-0189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Race: White