MAUDE Adverse Event Report: CONMED CORPORATION DYNA/TRACE FOAM WET GEL ADULT ECG ELECTRODE; DYNA/TRACE ECG ELECTRODE

Catalog Number 1555-005

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Partial thickness (Second Degree) Burn (2694)

Event Date 04/08/2014

Event Type  No Answer Provided  

Event Description

It was reported, "post scan, the patient was noticed to have developed a significant chest burn.The major burn area is in the location of the ecg electrode (patient far right).The other two electrode sites were red in appearance.The significant burn developed into a blister became infected.Icu consultant got medical photography to record the incident.".

Manufacturer Narrative

The original device will not be returned to conmed corporation.The device was saved by the clinical staff of the end-user facility; however, due to contamination status, this device cannot be returned from the uk to the united states.I apologize for the timing of this submission; however, i was waiting on details of the injury to the patient and treatment, if any prescribed, from the end-user facility to determine if this is a reportable event.The communications have remained unanswered, and, when checking on this complaint i realized i am past the 30 day submission requirement.I am unsure if this is a serious injury that is reportable, or not; therefore, i am submitting this medwatch submission a supplemental report will be filed on completion of the quality engineering evaluation.Unable to return device from the (b)(6).

Manufacturer Narrative

The device in question, catalog number 1555-005, is a dyna/trace mini stress foam wet gel adult ecg electrode.This device is an electrocardiograph electrode, an electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor via lead wires and cables that produce an electrocardiogram to be used by the clinician in diagnosing or monitoring a patient's condition.These electrodes are single use, disposable devices that are intended to be used by experienced and trained medical personnel in hospitals, clinics, physician offices and pre-hospital environments.(b)(4).This electrode has been tested and is an mri safe device.A review of the dhr/lhr, device history record/lot history record, verified that this lot number of ecg electrodes was confirmed by manufacturing documentation to have been produced according to manufacturing specifications.Proper manufacturing procedures were performed during manufacture to prevent non-conformances regarding the product's identity, quality, safety, effectiveness and performance.The original device will not be returned to conmed corporation.The device was saved by the clinical staff of the end-user facility; however, due to contamination status, this device cannot be returned from the uk to the united states.A review of complaint history for a twenty-four (24) month period reveals this as an isolated incident for the reported failure mode of a patient burn resultant from an mri radiological examination for all of the dyna/trace ecg electrode product line.Photographs have been requested of the end-user facility however; the end-user facility has responded that the photographs will not be made available to conmed corporation due to confidentiality issues.Therefore this incident cannot be conformed and the device involved cannot be confirmed as a conmed manufactured device.The patient that experienced the mri burn under an ecg electrode that occurred during an mri examination was examined in a 3 tesla mri scanner.It was reported that the ecg electrodes appeared to have dried out during the hour long scan.The three ecg electrodes were lined up side by side across the patient's chest and it seems the electrode on the right was effected the most.Conmed's ecg electrode products have been tested as mri safe in a testing performed by an independent contractor, dr.(b)(4).The main objectives of this mri safety testing were to determine the presence of magnetic field interactions, artifacts, and, heating for these devices in association with the use of an mri system.These tests were performed using a 1.5 tesla mri system (general electric co., signa system); therefore, results of the tests that were conducted are applicable to all mri systems with static magnetic field strengths of 1.5 tesla or less.The heating of the ecg electrodes during mri was determined by performing an extreme mri experiment with the ecg electrodes applied to a human subject.Temperature recordings were obtained in this experiment using a luxtron 3100 fluoroptic thermometry system previously demonstrated to be mri-compatible and unperturbed at static magnetic field strengths up to 9.0 tesla.This thermometry system has fiber-optic probes that have an accuracy and resolution of +/-0.1degree c.A fiber-optic probe was placed between the volunteer subject's skin and ecg electrode undersurface to record temperatures during mri.Baseline temperatures were recorded at one minute intervals for 5 minutes.Mri was then performed for 30 minutes, with temperatures being recorded at one minute intervals.The highest temperature changes measured for the ecg electrodes ranged from +0.2 to +0.5 degrees c (+0.2 to +0.4 degrees c for tested conmed products).This relative amount of heating is physiologically inconsequential and will not create a hazard or risk to a patient utilizing one of the ecg electrodes tested, and, undergoing an mri procedure under the conditions of the experiment.In summary, it was concluded that there should be no risks to patients undergoing mri procedures using mri systems operating at 1.5 tesla or less when utilizing any of the tested ecg electrodes.An mri safety and ecg electrode paper was written by conmed outlining the mathematics based in electromagnetism of inductive heating to explain the thermal effects of materials inside a strong magnetic field.An mri is usually graded as the strength of the coil field, e.G 3 tesla.This field is unchanging and is only one of the three magnetic fields that create the image in an mri scanner.A much smaller field, the gradient filed, is also applied and similarly unchanging.Resistive heating of an object is a function of time and of the flux over time of the other magnetic field; thus, the size of the coil and gradient magnetic fields does not influence the flux over time.Conclusions of this document state, "the field coil size does not matter as much as the size of the oscillating field which is always on a very small scale relative to the background fields.Thus, units that have been verified to be safe for use in 1.5t magnets would be inherently safe in 3t magnets." on the united states fda, food and drug administration, website it points out that, even though you may be using electrodes and cables that are approved for use during an mri, a serious burn can still develop if the electrodes aren't in complete contact with the skin surface (that is, if excess hair hasn't been removed or there's an air gap between the electrode and the skin).When there's an air gap, the electrical pathway is broken and heat can build up at the center of the electrode as well as letting the current arc from the electrode to the skin, which can cause burns.Don't let the cables form a loop and keep them off the patient's skin by placing a blanket under them.Http://www.Fda.Gov/cdrh/devicaldevicesafety/tipsarticles/electrodes.Html it is possible that the dyna/trace ecg electrode utilized in this procedure, even though an mr safe device, may not have been in complete contact with the patient's skin surface which may have contributed to the end result of the patient experiencing the mri related burn under the ecg electrode.The complaint device was not returned to conmed corporation by the end-user facility.The complaint investigation has not identified or confirmed any manufacturing defects associated with the suspect device; therefore, corrective action is not recommended at this time.Conmed is considering this complaint closed.

• Brand Name: DYNA/TRACE FOAM WET GEL ADULT ECG ELECTRODE
• Type of Device: DYNA/TRACE ECG ELECTRODE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 599
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 599
• Manufacturer Contact: stephen casanova, rn, mps ; 525 french road; utica, NY 13502-5994 ; 3156243463
• MDR Report Key: 3839390
• MDR Text Key: 17281627
• Report Number: 1320894-2014-00062
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K991105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 1555-005
• Device Lot Number: 1308021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2013
• 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): Other; Required Intervention