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Failure to Monitor a Patient’s Heart Condition Using a Loop Recorder

CATEGORIES: Misdiagnosis Wrongful Death Other Cases CASE LOCATION: Allegheny Co., PA. CLASSIFICATION: Substantial Recoveries

The Carter Case

Case Summary

Mr. Carter was implanted with a Medtronic loop recorder due to his history of chronic atrial fibrillation (AFib). Despite the implanted loop recorder, Mr. Carter’s AFib went unnoticed and untreated until he ultimately suffered a cerebrovascular accident (CVA).

Case Details

Mr. Carter, a 71 year-old man, was implanted with a Medtronic loop recorder, ordered by his cardiologist, Dr. Long. An implantable loop recorder is a type of heart-monitoring device that records an individual’s heart rhythm continuously for years at a time. The loop recorder documents the electrical signals of an individual’s heart and allows remote monitoring by way of a small device inserted just beneath the skin of the chest.

The process by which remote monitoring is performed involves a home base station, usually kept in the bedroom, which automatically interrogates the loop recorder each night, and transmits the recordings to Medtronic. The patient can also perform a manual interrogation and transmission for concerning symptoms. The individual physician has the option to select “actionable” events, but critical events are always determined to be actionable. Critical events include life threatening cardiac arrhythmias as well as substantial slowing of the heart rate. Episodes of AFib do not automatically default as an actionable event but may be chosen at the implanting physician’s discretion. Medtronic provides 24/7 monitoring that is staffed by specially trained ECG technicians.

Actionable events are called, emailed, or faxed to the physician immediately, but otherwise the physician office needs to connect to the Medtronic website to check for abnormal tracings, such as AFib, which are not automatically and directly reported to the physician. It is incumbent upon the monitoring physician (usually the implanting physician) to have an office policy and procedure in place to check the Medtronic website on a daily and regular basis for cardiac rhythm disturbances or symptom events. In this case, Dr. Long’s office charged a separate company with the responsibility of notifying his office if there were any reportable events.

Though Mr. Carter had a long history of AFib, it was not pathologic until January 2018. Mr. Carter had an AFib episode starting on January 20 that lasted for at least 4 days. Though Mr. Carter’s heart rhythm was being monitored remotely for this exact reason, Dr. Long’s office never informed him or his wife of the AFib that was occurring between January and February 2018. Therefore, Mr. Carter was never put on the proper medications to treat his condition. Since Mr. Carter was not properly medicated, he suffered a stroke that was cardiac in nature. Mr. Carter’s AFib events were only identified after the stroke occurred and the device was manually interrogated days later.

For a period of at least 23 days, no staff member of Dr. Long’s office checked the Medtronic website for any cardiac rhythm disturbances and no one in Dr. Long’s office was notified by the company responsible for doing so. The company responsible for notifying Dr. Long’s office had either no protocols or protocols that were severely insufficient in place to ensure that Dr. Long’s office staff read the strips produced by the loop monitor, notify Dr. Long about the strips or to notify the patient about any abnormalities displayed on the strips. Mr. Carter ultimately suffered a CVA in February 2018. As a result of the stroke, Mr. Carter now suffers with generalized weakness and cognitive deficits, which have significantly restricted his role in his family business.

Lawsuit

As we do in all our lawsuits, we sent this case out to a medical expert to review the case’s merits. Specifically, we sent this to a cardiac expert for his opinion, Dr. Smith. Dr. Smith opined that the treatment, or lack thereof, provided to Mr. Carter was inexcusable.

Dr. Smith opined that this was a clear case of negligence. If Mr. Carter’s AFib was recognized and treated at any time in January when he exhibited AFib and leading up to his CVA in February, Mr. Carter’s CVA could have been avoided by starting him on anticoagulation. There is currently a big problem in that a number of loop recorders are being placed in patients, but neither the physicians nor their office staff are signing into their respective programs daily, as they are supposed to, in order to check the status of patients. Additionally, there are critical alerts called to the physician’s office if there are prolonged pauses in a patient’s tracing. If no one is present to receive the call, those alerts can be missed.

Dr. Long clearly stated in his record that if AFib occurs, then there would be a “compelling indication” for anticoagulation when the recorder was initiated. Mr. Carter was in AFib for 11 days in January and for the beginning of February as well leading up to the stroke. It is clear that if Mr. Carter had his episodes of AFib timely identified by Dr. Long in January 2018 and had been immediately placed on direct oral anticoagulation as found to be “compelling” by Dr. Long, then the stroke would not have occurred.

Though we intended to sue the parties responsible for monitoring Mr. Carter’s heart condition, this action was settled before we ever filed a Complaint. Settling a case pre-Complaint is rather unusual, however, adding to the rarity of this case, Dr. Long acknowledged the errors in the operating system that caused significant harm. Dr. Long’s acknowledgment of the critical errors that led to Mr. Carter’s CVA helped a great deal in settling this case sooner.

Even with Dr. Long’s cooperation, this case included plenty of obstacles. One of the main issues in this case, as we find in many cases, was obtaining Mr. Carter’s medical records. It took many months and numerous correspondences with Defense Counsel and the hospital to obtain the heart tracings from the loop recorder. Despite our numerous requests, the company responsible for alerting Dr. Long’s office to Mr. Carter’s cardiac abnormalities gave us an extremely difficult time before ultimately producing Mr. Carter’s heart tracings. After our repeated requests, we finally obtained the heart tracings, which showed the utter failure of the company responsible for recognizing Mr. Carter’s episodes of AFib to alert Dr. Long’s office of the same.

Result

Prior to a Complaint being filed, we reached an agreement for a substantial settlement.