Millions of people across the world have a pacemaker implanted as a way to repair damaged hearts. A successful pacemaker implant can prolong a quality of life for years to come. Pacemakers can be for people with congenital heart defects, heart disease, or other heart problems.
Most pacemaker surgeries are successful but some can involve complications. Artificial heart problems can involve negligent surgery, anesthesia malpractice, or defective pacemakers. Don’t assume problems with your pacemaker are just a risk of the procedure. If you were injured because of a defective pacemaker or medical malpractice, it is important to speak out to help others avoid a similar outcome.
When a patient is the victim of medical malpractice, they can hold the doctors and hospital accountable for their losses, including medical bills, corrective surgery, and pain and suffering. If you suffered an injury caused by a doctor’s negligence, contact an experienced personal injury and medical malpractice law firm for help.
The heart has a natural cardiac pacemaker, which is a muscle that controls the rate of cardiac contractions or heartbeats. In a healthy heart, the pacemaker controls the heart rate at a steady level based on the body’s need for oxygen to pump oxygenated blood through the body, to the brain, vital organs, and all other cells. The heart also has a natural backup, known as the secondary pacemaker.
When the natural pacemaker is unable to continue functioning, generally due to arrhythmia, age, or other medical conditions, an artificial pacemaker can be used to synthetically produce electrical impulses to regulate the heart’s contractions. The artificial pacemaker is an implanted medical device that takes over control of the natural sinoatrial pacemaker to regulate the beating of the heart.
Types of Pacemakers
The first successful cardiac pacemaker implant was in 1960. The first patient, a 77-year-old man, lived 10 months after the surgery. Other patients who had the surgery the same year lived more than 20 years after the surgery. There are a few different types of pacemakers and implantable defibrillators. Depending on the patient’s medical condition, pacemakers include:
- Single-chamber pacemakers (for the right ventricle)
- Dual-chamber pacemaker (for the right ventricle and the right atrium)
- Biventricular pacemaker (for both the right and left ventricles in the lower heart chamber)
Modern pacemakers weigh as little as one ounce, and the procedure only takes about one hour using a small incision. According to a report published in the Journal of the American College of Cardiology, there has been a continual increase in patients receiving permanent pacemakers in the U.S., especially for dual-chamber (DDD) devices. “Between 1993 and 2009, 2.9 million patients received permanent pacemakers in the United States.”
An artificial heart pacemaker can increase life in patients for 5 or more years. However, survival rates are often based on other medical issues, or “comorbidities.” Comorbid conditions that can impact survival rates include liver disease, peripheral vascular disease, diabetes, and chronic obstructive pulmonary disease (COPD). While these conditions can be contributors to reduced life-expectancy rates, hospitals may blame these conditions for patient deaths that were actually caused by medical malpractice.
Before undergoing surgery to implant an artificial pacemaker, your medical team will conduct a number of tests to make sure you are a good candidate for pacemaker surgery. This includes several heart monitoring diagnostic tests, including:
- Electrocardiograms (EKGs)
- Heart monitoring (Holter monitor device)
- Echocardiograms (using soundwaves)
- Stress echo tests (heart test during exercises)
An incision is made on the chest below the collarbone. The pacemaker generator is implanted, with the leads through the veins and into the heart. Most patients can go home within a day of the procedure. Like any other invasive surgery, implanting a pacemaker comes with risks. Some of these risks are risks associated with any surgery and may be unavoidable. Risks of a surgical procedure can include:
- Surgical site infection
- Bleeding at the surgical site
- Anesthesia complications
- Blood clots
- Nerve damage
- Damage to blood vessels
- Hemothorax (blood in the space between the lungs and chest wall)
- Collapsed lung (pneumothorax)
- Cardiac perforation
However, the risks of surgery are different from medical errors, which are avoidable. When a doctor, nurse, surgeon, or anesthesiologist does not follow the standards of medical care, it can cause injury or death to the patient. This is not a risk of surgery. Instead, it is negligence. It is important for patients to hold doctors accountable for their mistakes. Calling out malpractice can improve healthcare in the long run and make sure the patient is compensated for their injuries.
Electrical Interference With Pacemaker Implant
The pacemaker works by delivering electrical impulses to the muscles in the heart. However, electrical interference in the environment can cause problems with the functioning of the pacemaker, even from a cell phone. Patients may have to keep their phone away from the area of the pacemaker. Other causes of interference can include:
- X-ray machines at the airport
- MRI tests
- CT scans
- Radiation treatment
- Welding equipment
- Motor-generator systems
- High-voltage transformers
Anesthesia During Pacemaker Surgery
In many artificial pacemaker surgeries, the patient is awake during the procedure. Patients may be given a local anesthesia or sedation, which will numb the area where the surgery will occur. This will help the patient relax and not feel the full effects of surgery as without the sedative. If you are concerned about sedation or anesthesia during heart surgery, talk to your surgeon about your options.
Other heart surgeries involve general anesthesia for the procedure, which can involve its own risks. Anesthesia is very common but can be dangerous. Anesthesia for heart surgery generally uses a combination of drugs to sedate the patient, comfort the patient, and “put them under,” so they are immobilized and will not feel pain during the surgery.
Anesthesia requires careful monitoring of the patient’s vital signs, including heart rate and breathing rate or oxygenation of the blood. In some cases, the patient is intubated (a tube is inserted to keep the airway open), and artificially respirated. Without careful monitoring, the patient may suffer cardiac arrest or hypoxia (not enough oxygen). Even a few minutes without enough oxygen can cause organ damage and cell death. If hypoxia is not treated quickly enough, the patient can diet.
Most anesthesia errors are not just because of the risks of anesthesia. One study found that more than 80% of preventable incidents were caused by human error. These errors included:
- Too much anesthesia
- Not enough anesthesia
- Prescription drug errors
- Failure to monitor the patient
- Communication errors or hand-off errors
- Adverse reactions
- Intubation injuries
When the anesthesiologist fails to follow the standards of medical care when administering anesthesia and monitoring the patient, it can cause serious injuries, including brain damage from lack of oxygen. If a patient stops breathing and is not administered oxygen, the cells and organs in the body quickly begin to shut down. Cell death can begin within minutes of having the oxygen supply cut off.
Causes of Artificial Pacemaker Malpractice
There are risks of medical errors involving pacemaker surgery. When a doctor or surgeon fails to follow the standards of medical care, it can result in a medical malpractice injury. Some causes of injuries with a pacemaker surgery include:
- Misdiagnosis or delayed diagnosis
- Surgical errors
- Damage to internal organs
- Hospital-acquired infection from unsterilized equipment
- Wrong body part surgery
- Wrong patient surgery
- Wrong side surgery
- Left behind foreign object
- Failure to monitor patient
- Using a defective implant
When a doctor makes a diagnosis of heart problems, an artificial pacemaker may be the best treatment option for the patient. However, if the patient’s condition is not caused by a problem with the heart rate or functioning of the natural pacemaker, an artificial pacemaker could be unnecessary. Unnecessary surgery involves risks and an expensive medical procedure. The patient may also be limited with an artificial pacemaker.
Even though most artificial pacemaker surgeries are relatively quick and common, there are problems that can happen during any surgery. Heart surgeons may be scheduled for multiple pacemaker surgeries back-to-back. If a surgeon is too tired after multiple surgeries, they may be more likely to make a mistake during surgery.
Surgical errors can also be caused by hospitals or surgical centers that do not follow proper surgical protocols. This can lead to so-called “never events,” which are mistakes or errors that are avoidable and indicate negligence. Types of surgical never events include wrong-patient surgery or wrong procedure. For example, if a hospital gets patients mixed up, it may perform a pacemaker implant on one and a kidney removal on the other. The patients may be unaware of the error if they are under the influence of anesthesia.
Another surgical never-event error involves foreign objects left behind in the body. During surgery, the surgeon may insert gauze, forceps, or needles inside the patient’s body. If the doctor and surgical team do not account for all the objects, it could result in a foreign object getting left behind in the patient. Left-behind surgical items can cause infection, tissue damage, sepsis, or death. However, it may take months or longer before the patient discovers the cause of their injuries.
There are many types of bacteria, viruses, and fungi all around us. Most of the time, the body’s natural immune system is enough to keep us from contracting a serious infection. However, with surgery, the opening up of the body to implant the pacemaker can introduce infection into the body.
A healthcare-acquired infection (HAI) is an infection the patient gets when they are in the hospital or medical facility. HAIs can be caused by failure to properly clean and sanitize the facility, not washing hands properly, not wearing personal protective equipment, or using unsterilized surgical instruments.
Defective Artificial Pacemakers
When a pacemaker works as intended, it can help the patient lead an active and healthy life. However, like other types of medical equipment, design or manufacturing defects can lead to serious injury or death. Over the years, thousands of pacemaker models have been recalled because of safety concerns. Pacemaker brands that have had recalls include:
- Medtronic pacemakers
- Spring Fidelis cardiac leads
- Boston Scientific pacemakers
- Ingenio pacemakers and CRT-Ps
- Abbott/St. Jude Medical pacemakers
- Assurity pacemakers
- Endurity pacemakers
For example, an estimated 48,000 Boston Scientific INGENIO pacemakers were recalled because of a risk of transitioning to safety mode. In safety mode, “there is a risk of inappropriate loss of pacing due to sensing of muscle contractions.” According to the recall, there were 65 reported incidents and risks included “loss of pacing or ability to regulate heart rate with serious or life threatening injury, worsening of heart failure, and death.”
More than 60,000 Abbott/St.Jude Medical Assurity and Endurity pacemakers were recalled in 2021. Patients with faulty pacemakers could suffer fainting, shortness of breath, tiredness, dizziness, and discomfort. There were 135 complaints and injuries reported when moisture got into the device, causing an electrical short, leading to:
- A loss of device pacing
- Telemetry failure or errors in information
- Early and fast battery drain
- Less time between the first battery depletion warning
How Can a Medical Malpractice Lawyer Help?
After a medical injury, the patient may feel helpless and not know where to turn. The hospitals and doctors may deny anything went wrong or even ignore you after you report a problem. If you don’t pursue your case, then the hospitals won’t hold anyone accountable and won’t take action to prevent others from suffering a similar injury.
If you contact a medical malpractice attorney, they can give you confidence that you finally have an advocate on your side. Your medical malpractice attorney can review your medical records and identify what went wrong and who was responsible. Once the hospital gets a call from an experienced malpractice attorney, they will suddenly take your injuries very seriously.
Filing a medical malpractice lawsuit is also a way to recover compensation for your injuries. If the doctor or hospital was responsible for causing your injuries, they should be responsible for paying for the damages. Damages in a malpractice lawsuit can include medical bills, future medical care, payment for lost income, and money for pain and suffering.
Contact experienced trial attorneys who have successfully represented negligent heart surgery victims. Call a malpractice lawyer to find out more about your case and what kind of damages you can recover. For a free consultation, contact Gilman & Bedigian online or at 800-529-6162.