Coding for Device Associated Adverse Events

Coding for Device Associated Adverse Events

Although we don’t like to think about it, complications of surgical and medical care are a reality of life.  Some complications are attributed to medical care while others are related to medical devices.  Due to the serious nature of a device-associated adverse incident, it is imperative for coders to know the documentation requirements, the classification of complications, and the difference between these and later complications. Additionally, we must understand the impact of device complications in coding, statistical reporting, and legal matters.

It is fairly common to come across conditions resulting from device complications while coding.  Two codes are generally reported from Chapters 19 and 20 of the ICD-10-CM book to fully capture the specific complication, the type of device, and whether it is considered a misadventure towards the patient during care, an adverse incident, or a later complication.  A later complication generally involves expected outcomes where there is no serious harm, injury, or death; however, it can involve unexpected outcomes that are not truly a result of a defective device or caused by the device.  Adverse incidents generally pertain to unexpected or unintended outcomes that have resulted in serious harm, injury, or death.

In general, when a device is associated with an adverse incident, it means that there is a problem with the device itself. This is usually some sort of mechanical failure or the device is simply defective.  An adverse incident code (Y70-Y82) from Chapter 20 will normally be reported in conjunction with a breakdown or malfunction code (T82-T85) from Chapter 19 as directed by the Includes Note in the tabular section of the ICD-10-CM book prior to the adverse incident codes, as well as, the “Surgical or Medical Care as External Cause” section of the AHA Coding Handbook.  This means that other device-related complications are generally reported as a later complication unless otherwise specified by the provider in the documentation.  Some examples of later complications include device-related pain, infection, stent stenosis, displacement, obstruction, protrusion, leakage. Also included here are devices that are functioning appropriately but not providing anticipated results, such as a neurostimulator not relieving pain as expected.

To better understand what might be considered an adverse incident, imagine an implanted pacemaker with a broken lead.  If that broken lead only results in the pacemaker not functioning as intended without causing any actual harm to the patient, it would be considered a later complication unless documentation reflects otherwise.  However, if that broken lead punctures a blood vessel or heart structure that leads to emergency surgery, permanent injury, or even death, then there is a strong possibility that it would be considered an adverse incident.

Medical Coders should never assign an adverse incident code simply because there is a device complication.  It is the responsibility of the provider to document when a device is linked to an adverse incident.  These incidents are extremely serious, which is why they are supposed to be reported to the manufacturer and the FDA. There is the potential for criminal and/or civil penalties with failure to do so.  The FDA uses the data to alert the public in an effort to prevent future injuries and/or deaths.  Device-related adverse incidents can also lead to lawsuits and other legal matters.  For these reasons, medical coders should only report an adverse incident Chapter 20 code if the physician documentation clearly supports it. 

In Summary: Medical coders need to understand and be aware of the serious nature behind these codes, in addition to the possible repercussions for all the parties involved.  The determination that a device has caused an adverse incident is the sole responsibility of the provider; and documentation should clearly support the code assignment.  Query the physician if there is documentation of a serious injury or patient death as the result of a device without clear documentation that an adverse incident has occurred.  However, if there is no documentation of a serious injury or that an adverse incident has occurred, a later complication code should be reported rather than an adverse event.  We are obligated to get these coded correctly!

Tarah  Lee, CCS

LexiCode Quality Assurance Analyst


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Post Acute Medical