Patient is Killed During Pacemaker Removal Surgery

ByJoseph O'Neill

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Updated onOctober 3, 2017

Patient is Killed During Pacemaker Removal Surgery

This case takes place in New York and involves a female patient who had a pacemaker placed. The leads used were manufactured by a well-known medical device manufacturer, and were to be monitored for lead failure. Several years after the pacemaker was placed, the patient presented to her cardiologist – at which point it was recommended that they remove one of the leads. During surgery for removal of the lead, the surgeon decided to remove an additional lead. A complication occurred during this part of the procedure, resulting in the patient passing away. While a complication like the one identified is a known risk of the procedure, there was no informed consent to remove the additional lead for this patient. Further, this had never been discussed with the patient and her family. Medically, there was no reason to remove this lead as it had been functioning properly.

Question(s) For Expert Witness

1. Do you routinely perform the procedure in question?

2. If so, do you believe it's a departure from the SOC to remove a lead without a signed informed consent / discussing this procedure with the patient?

3. Intra-operatively, given the presence of significant blood and a large laceration, should the procedure have been aborted or, at the very least, should radiographic testing been ordered?

Expert Witness Response E-006662

inline imageI do perform this procedure. Although we routinely tell patients ahead of time that we always prepare for all possibilities during these procedures, it often is difficult to predict whether another lead may need to be removed as well. Sometimes the other lead needs to be removed to facilitate the removal of the problematic lead. Therefore I believe this does occur sometimes, though again we try to tell patients that unforeseen circumstances may change our procedure. A new pericardial effusion during an extraction procedure almost always means there has been a tear of some type. This is presumably why the cardiac surgeons were called into the procedure. I would have to examine the details and timing of what occurred next, whether there was intervention for the pericardial effusion at its initial discovery. That should have prevented the patient's demise.

About the author

Joseph O'Neill

Joseph O'Neill

Joe has extensive experience in online journalism and technical writing across a range of legal topics, including personal injury, meidcal malpractice, mass torts, consumer litigation, commercial litigation, and more. Joe spent close to six years working at Expert Institute, finishing up his role here as Director of Marketing. He has considerable knowledge across an array of legal topics pertaining to expert witnesses. Currently, Joe servces as Owner and Demand Generation Consultant at LightSail Consulting.

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